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12FEB16 FDA Enforcement Report RECALLS .pdf


Original filename: 12FEB16_FDA_Enforcement Report_RECALLS.pdf
Title: 12FEB16_FDA_Enforcement Report_RECALLS.xlsx
Author: tdraschil

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Product Type

Product Description

Code Info

Classification

Reason for Recall

Recalling Firm

Biologics

Source Plasma

OL0494493; OL0495217;
OL0496980; OL0497940;
OL0499474; OL0500401

Class II

Blood products, for which donor
suitability was inadequately
determined, were distributed.

BPL Plasma, Inc.

Biologics

Apheresis Red Blood Cells, Leukocytes Reduced

W036815047136 (double
collection)

Class III

Misbranded red blood cells,
were distributed.

OneBlood, Inc.

Biologics

Cornea

Class II

Human cornea, not tested
adequately and appropriately to
reduce the risk of transmission
of relevant communicable
diseases, was distributed.

Alabama Eye Bank

Biologics

Apheresis Platelets, Leukocytes Reduced, Irradiated

W201815816599;
W201815816609 (double)

Class II

Biologics

Blood and Blood Products for Reprocessing

W200315444309

Class III

American National
Red Cross Great
Lakes Region
The American
National Red Cross Southern Region

Biologics

Pooled Cryoprecipitated AHF

W200315913640

Class II

Devices

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN  Software Version 1.0.3
11127538 Clinical chemistry analyzer that runs tests on serum, 
plasma, urine, or cerebral spinal fluid in random access and 
batch modes at a throughput rate of both 1800 photometric 
tests per hour and 600 electrolyte (ISE) tests per hour.

Class II

Apheresis Leukoreduced
products, with an elevated WBC
count, were distributed.
Blood products, collected from a
donor for whom donor suitability
was not adequately determined,
were distributed.
Blood products, collected from a
donor for whom donor suitability
was not adequately determined,
were distributed.
Multiple Software issues. Auto
Start-UP Fail, Calibration
Interval Resets when a Reagent
Blank is run, Control Definition
screen assumes range defined is
2 SD, Laboratory Information
System (LIS)
communication/Laboratory
Automation (LAS) issue, Printer
Driver Resets, ISE Calibration
Ranges are too conservative for
Urine Sodium, Archiving and
deletion may fail and
Workstation services may
restart.

Devices

All serial numbers.
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 
722026 722010 722003 722002 722001 Intended for 
Cardiovascular and vascular X‐ray imaging applications, 
including diagnostic, interventional procedures (such as PTCA, 
stent placement and atherectomies), pacemaker 
implantations and ElectroPhysiology (EP).

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Allura Xper FD10/10; Model Numbers: 722027 722011 722005  All serial numbers
Intended for Cardiovascular and vascular X‐ray imaging 
applications, including diagnostic, interventional procedures 
(such as PTCA, stent placement and atherectomies), 
pacemaker implantations and ElectroPhysiology (EP).

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Allura Xper FD10 OR Table; Model Numbers: 722033 722022  All serial numbers
Intended for Cardiovascular and vascular X‐ray imaging 
applications, including diagnostic, interventional procedures 
(such as PTCA, stent placement and atherectomies), 
pacemaker implantations and ElectroPhysiology (EP).

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

152213

The American
National Red Cross Southern Region
Siemens Healthcare
Diagnostics, Inc.

Devices

All serial numbers
Allura Xper FD20/10; Model Numbers: 722029 Dedicated 
vascular and neurovascular imaging applications, including 
diagnostic and interventional procedures. This includes, e.g. 
peripheral, cerebral, thoracic and abdominal angiography, as 
well as PTCAs, stent placements, embolisations and 
thrombolysis. " Cardiac imaging applications including 
diagnostics, interventional procedures (such as PTCA, stent 
placing, atherectomies), pacemaker implantations and 
ElectroPhysiology " Non‐vascular interventions such as 
drainages, biopsies and vertebroplasties procedures

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
Allura Xper FD20/15; Model Numbers: 722058 Dedicated 
vascular and neurovascular imaging applications, including 
diagnostic and interventional procedures. This includes, e.g. 
peripheral, cerebral, thoracic and abdominal angiography, as 
well as PTCAs, stent placements, embolisations and 
thrombolysis. " Cardiac imaging applications including 
diagnostics, interventional procedures (such as PTCA, stent 
placing, atherectomies), pacemaker implantations and 
ElectroPhysiology " Non‐vascular interventions such as 
drainages, biopsies and vertebroplasties procedures

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
Allura Xper FD20; Model Numbers: 722028 722012 722006 
Dedicated vascular and neurovascular imaging applications, 
including diagnostic and interventional procedures. This 
includes, e.g. peripheral, cerebral, thoracic and abdominal 
angiography, as well as PTCAs, stent placements, 
embolisations and thrombolysis. " Cardiac imaging 
applications including diagnostics, interventional procedures 
(such as PTCA, stent placing, atherectomies), pacemaker 
implantations and ElectroPhysiology " Non‐vascular 
interventions such as drainages, biopsies and vertebroplasties 
procedures

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is 
intended for use on human patients to perform: " Vascular, 
cardiovascular and neurovascular imaging applications, 
including diagnostic, interventional and minimally invasive 
procedures. This includes, e.g., peripheral, cerebral, thoracic 
and abdominal angiography, as well as PTAs, stent 
placements, embolisations and thrombolysis. " Cardiac 
imaging applications including diagnostics, interventional and 
minimally invasive procedures (such as PTCA, stent placing, 
atherectomies), pacemaker implantations, and 
electrophysiology (EP). " Non‐vascular interventions such as 
drainages, biopsies and vertebroplasties procedures

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

UNIQ FD OR table; Model Number 722035 The Philips UNIQ is  All serial numbers
intended for use on human patients to perform: " Vascular, 
cardiovascular and neurovascular imaging applications, 
including diagnostic, interventional and minimally invasive 
procedures. This includes, e.g., peripheral, cerebral, thoracic 
and abdominal angiography, as well as PTAs, stent 
placements, embolisations and thrombolysis. " Cardiac 
imaging applications including diagnostics, interventional and 
minimally invasive procedures (such as PTCA, stent placing, 
atherectomies), pacemaker implantations, and 
electrophysiology (EP). " Non‐vascular interventions such as 
drainages, biopsies and vertebroplasties procedures

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Allura Xper FD20 OR Table; Model Numbers: 722035 722023  All serial numbers
Dedicated vascular and neurovascular imaging applications, 
including diagnostic and interventional procedures. This 
includes, e.g. peripheral, cerebral, thoracic and abdominal 
angiography, as well as PTCAs, stent placements, 
embolisations and thrombolysis. " Cardiac imaging 
applications including diagnostics, interventional procedures 
(such as PTCA, stent placing, atherectomies), pacemaker 
implantations and ElectroPhysiology " Non‐vascular 
interventions such as drainages, biopsies and vertebroplasties 
procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Allura Xper FD20 Biplane; Model Numbers: 722013 722008 
722015 Dedicated vascular and neurovascular imaging 
applications, including diagnostic and interventional 
procedures. This includes, e.g. peripheral, cerebral, thoracic 
and abdominal angiography, as well as PTCAs, stent 
placements, embolisations and thrombolysis. " Cardiac 
imaging applications including diagnostics, interventional 
procedures (such as PTCA, stent placing, atherectomies), 
pacemaker implantations and ElectroPhysiology " Non‐
vascular interventions such as drainages, biopsies and 
vertebroplasties procedures.

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Allura Xper FD20 Biplane OR Table; Model Numbers: 722025  All serial numbers
722020 Dedicated vascular and neurovascular imaging 
applications, including diagnostic and interventional 
procedures. This includes, e.g. peripheral, cerebral, thoracic 
and abdominal angiography, as well as PTCAs, stent 
placements, embolisations and thrombolysis. " Cardiac 
imaging applications including diagnostics, interventional 
procedures (such as PTCA, stent placing, atherectomies), 
pacemaker implantations and ElectroPhysiology " Non‐
vascular interventions such as drainages, biopsies and 
vertebroplasties procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
Allura Xper FD20/20; Model Number: 722038 Dedicated 
vascular and neurovascular imaging applications, including 
diagnostic and interventional procedures. This includes, e.g. 
peripheral, cerebral, thoracic and abdominal angiography, as 
well as PTCAs, stent placements, embolisations and 
thrombolysis. " Cardiac imaging applications including 
diagnostics, interventional procedures (such as PTCA, stent 
placing, atherectomies), pacemaker implantations and 
ElectroPhysiology " Non‐vascular interventions such as 
drainages, biopsies and vertebroplasties procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
Allura Xper FD20/20 OR Table; Model Number: 722039 
Dedicated vascular and neurovascular imaging applications, 
including diagnostic and interventional procedures. This 
includes, e.g. peripheral, cerebral, thoracic and abdominal 
angiography, as well as PTCAs, stent placements, 
embolisations and thrombolysis. " Cardiac imaging 
applications including diagnostics, interventional procedures 
(such as PTCA, stent placing, atherectomies), pacemaker 
implantations and ElectroPhysiology " Non‐vascular 
interventions such as drainages, biopsies and vertebroplasties 
procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
Allura CV20; Model Number: 722031 The Allura CV2O is 
intended for physicians (e.g. cardiologists and radiologists), 
assisted by trained hospital staff (e.g. nurses and lab 
technicians), who are qualified to perform medical procedures 
on humans (having a maximum weight of 250 kg.) with 
probable internal diseases or injuries for: " Dedicated vascular 
and carotid imaging applications, including diagnostic and 
interventional procedures. " Cardiac imaging applications 
including diagnostics, interventional rocedures, pacemaker 
implantations and electrophysiology (EP). " Non‐vascular 
interventions such as drainages, biopsies and vertebroplasties 
procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Cardiovascular Allura Centron; Model Number: 722400 The  All serial numbers
Allura CV2O is intended for physicians (e.g. cardiologists and 
radiologists), assisted by trained hospital staff (e.g. nurses and 
lab technicians), who are qualified to perform medical 
procedures on humans (having a maximum weight of 250 kg.) 
with probable internal diseases or injuries for: " Dedicated 
vascular and carotid imaging applications, including diagnostic 
and interventional procedures. " Cardiac imaging applications 
including diagnostics, interventional rocedures, pacemaker 
implantations and electrophysiology (EP). " Non‐vascular 
interventions such as drainages, biopsies and vertebroplasties 
procedures.

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS  All serial numbers
3000 I 5000 system is intended for interventional and 
diagnostic vascular and neurovascular procedures. The Philips 
INTEGRIS Allura 9 Biplane system is intended for diagnostic 
cardiovascular, vascular and interventional procedures. The 
Philips INTEGRIS Allura 12 & 15 system is intended for 
peripheral, abdominal, cerebral diagnostic and interventional 
angiography, neuro applications, cardiac applications and non‐
vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS HM3000; Model Number: 72239 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS BN/BV3000; Model Number: 72240 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS BH3000; Model Number: 72242 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS V3000; Model Number: 72243, 72244, 72245 The  All serial numbers
Philips INTEGRIS 3000 I 5000 system is intended for 
interventional and diagnostic vascular and neurovascular 
procedures. The Philips INTEGRIS Allura 9 Biplane system is 
intended for diagnostic cardiovascular, vascular and 
interventional procedures. The Philips INTEGRIS Allura 12 & 15 
system is intended for peripheral, abdominal, cerebral 
diagnostic and interventional angiography, neuro applications, 
cardiac applications and non‐vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS  All serial numbers
3000 I 5000 system is intended for interventional and 
diagnostic vascular and neurovascular procedures. The Philips 
INTEGRIS Allura 9 Biplane system is intended for diagnostic 
cardiovascular, vascular and interventional procedures. The 
Philips INTEGRIS Allura 12 & 15 system is intended for 
peripheral, abdominal, cerebral diagnostic and interventional 
angiography, neuro applications, cardiac applications and non‐
vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS BH5000; Model Number: 72247 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS  All serial numbers
3000 I 5000 system is intended for interventional and 
diagnostic vascular and neurovascular procedures. The Philips 
INTEGRIS Allura 9 Biplane system is intended for diagnostic 
cardiovascular, vascular and interventional procedures. The 
Philips INTEGRIS Allura 12 & 15 system is intended for 
peripheral, abdominal, cerebral diagnostic and interventional 
angiography, neuro applications, cardiac applications and non‐
vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS BV5000: Model Number: 72249 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

All serial numbers

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers
INTEGRIS Allura 9 (biplane); Model Number: 722021 The 
Philips INTEGRIS 3000 I 5000 system is intended for 
interventional and diagnostic vascular and neurovascular 
procedures. The Philips INTEGRIS Allura 9 Biplane system is 
intended for diagnostic cardiovascular, vascular and 
interventional procedures. The Philips INTEGRIS Allura 12 & 15 
system is intended for peripheral, abdominal, cerebral 
diagnostic and interventional angiography, neuro applications, 
cardiac applications and non‐vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS Allura 15‐12 (mono); Model Number: 722043 The  All serial numbers
Philips INTEGRIS 3000 I 5000 system is intended for 
interventional and diagnostic vascular and neurovascular 
procedures. The Philips INTEGRIS Allura 9 Biplane system is 
intended for diagnostic cardiovascular, vascular and 
interventional procedures. The Philips INTEGRIS Allura 12 & 15 
system is intended for peripheral, abdominal, cerebral 
diagnostic and interventional angiography, neuro applications, 
cardiac applications and non‐vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS Allura 15‐12 (biplane); Product Code: 722044 The  All serial numbers.
Philips INTEGRIS 3000 I 5000 system is intended for 
interventional and diagnostic vascular and neurovascular 
procedures. The Philips INTEGRIS Allura 9 Biplane system is 
intended for diagnostic cardiovascular, vascular and 
interventional procedures. The Philips INTEGRIS Allura 12 & 15 
system is intended for peripheral, abdominal, cerebral 
diagnostic and interventional angiography, neuro applications, 
cardiac applications and non‐vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

All serial numbers.
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 
3000 I 5000 system is intended for interventional and 
diagnostic vascular and neurovascular procedures. The Philips 
INTEGRIS Allura 9 Biplane system is intended for diagnostic 
cardiovascular, vascular and interventional procedures. The 
Philips INTEGRIS Allura 12 & 15 system is intended for 
peripheral, abdominal, cerebral diagnostic and interventional 
angiography, neuro applications, cardiac applications and non‐
vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

INTEGRIS BV3000 MONO; Model Number: 72241 The Philips 
INTEGRIS 3000 I 5000 system is intended for interventional 
and diagnostic vascular and neurovascular procedures. The 
Philips INTEGRIS Allura 9 Biplane system is intended for 
diagnostic cardiovascular, vascular and interventional 
procedures. The Philips INTEGRIS Allura 12 & 15 system is 
intended for peripheral, abdominal, cerebral diagnostic and 
interventional angiography, neuro applications, cardiac 
applications and non‐vascular interventions

Class II

The use of Allura Xper, Allura
Philips Electronics
Clarity, Allura CV, Allura Centron North America
and UNIQ systems regarding live Corporation
images and still images can lead
to still images being interpreted
as live Images.

Devices

Panorama Patient Monitoring Network. Software Kit 0020‐00‐ version 11.5.1
0205‐19A, View Station Software Kit 0020‐00‐0206‐16A, Work 
Station Software Kit 0020‐00‐0207‐16A, Software Kit Upgrade 
TECH‐00‐910. The Panaroma Patient Monitoring Network is 
intended for use in a fixed location in the healthcare facility 
setting as a central viewing station. It is not intended to be 
directly connected to patient at any time or installed in a 
patient's vicinity.

Class II

An issue with the Panorama
Mindray DS USA,
Central Station may cause the
Inc. dba Mindray
system to spontaneously restart. North America
This may occur after about 49
days of continuous operation.
On restart, monitoring will be lost
for about 2.5 minutes. Settings
and configurations are
maintained.

Devices

Lot Numbers: 50409038,
Biosure Driver, Product No: 72201887 For delivery and 
placement of orthopedic screws. Orthopedic Manual Surgical  50404149, 50399964
Instrument

Class II

Driver does not meet
Smith & Nephew,
specification, oversized. Driver
Inc., Endoscopy Div.
may not be able to be fully
inserted into the screw, or screw
may become stuck on the driver.

All serial numbers.

Devices

Biosure Ratchet Driver, Product No: 72201888 For delivery 
and placement of orthopedic screws. Arthroscopic surgical 
instrument

Lot Numbers: 50410950 and
50407175

Class II

Driver does not meet
Smith & Nephew,
specification, oversized. Driver
Inc., Endoscopy Div.
may not be able to be fully
inserted into the screw, or screw
may become stuck on the driver.

Devices

MediChoice Cohesive Bandages, One (1) roll of cohesive 
bandage per bag, thirty‐six (36) bags per case [all model 
numbers have equivalent packaging]. General Hospital Use.

Item No. Lot No. Expiration
Date: CBN1103 12113H08A Oct15, CBN1103 13033H08A Feb16, CBN1103 13053H08A Apr16, CBN1103 14013H08A Dec16, CBN1103 14043H08A Mar17, CBN1103 14053H08A Apr17, CBN1103 14083H08A Jul17, CBN1103 14063H08A May17, CBN1103 15013H08A Dec17, CBN1103 14123H08A Nov17, CBN1103 14113H08A Oct17, CBN1103 15023H08A Jan18, CBN1103 15033H08A Feb18, CBN1103 15043H08A Mar18, CBN1103 15053H08A ...

Class II

MediChoice sterile cohesive
Owens & Minor
bandages imported and sold
Distribution, Inc.
under a private brand by Owens
& Minor were tested and found
to have microbial contamination.

Devices

MediChoice Cohesive Bandages, One (1) roll of cohesive 
bandage per bag, thirty‐six (36) bags per case [all model 
numbers have equivalent packaging] General Hospital Use.

Item No. Lot No. Expiration
Date: CBN1104 15023H09A Jan18, CBN1104 15033H09A Feb18, CBN1104 15043H09A Mar18, CBN1104 15053H09A Apr18, CBN1104 15063H09A May18, CBN1104 15073H09A Jun18, CBN1104 15083H09A Jul18, CBN1104 14113H09A Oct17, CBN1104 14123H09A Nov17, CBN1104 15013H09A Dec17, CBN1104 14063H09A May17, CBN1104 14083H09A Jul17, CBN1104 14093H09A Aug17, CBN1104 14053H09A Apr17, CBN1104 14043H09A ...

Class II

MediChoice sterile cohesive
Owens & Minor
bandages imported and sold
Distribution, Inc.
under a private brand by Owens
& Minor were tested and found
to have microbial contamination.

Devices

MediChoice Cohesive Bandages, One (1) roll of cohesive 
bandage per bag, thirty‐six (36) bags per case [all model 
numbers have equivalent packaging] General Hospital Use.

Item No. Lot No. Expiration
Date, CBN1106 12113H10A Oct15, CBN1106 13033H10A Feb16, CBN1106 13053H10A Apr16, CBN1106 13083H10A Jul16, CBN1106 13103H10A Sep16, CBN1106 13113H10A Oct16, CBN1106 14013H10A Dec16, CBN1106 14043H10A Mar17, CBN1106 14053H10A Apr17, CBN1106 14063H10A May17, CBN1106 14083H10A Jul17, CBN1106 14093H10A Aug17, CBN1106 14093H10A Aug17, CBN1106 14113H10A Oct17, CBN1106 14123H10A ...

Class II

MediChoice sterile cohesive
Owens & Minor
bandages imported and sold
Distribution, Inc.
under a private brand by Owens
& Minor were tested and found
to have microbial contamination.

Devices

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU  Lot Number 08915J 09015T
014613) and CPT2000 (SKU 014623) Automated Manifold Kits,  09115H 09315D 09615N
09615U 09715X 09815F
Sterile R, Rx Only, Made in Mexico. The manifold body is 
10115D 10215G 10415D
identical in the BT2000 and CPT2000 kits. The BT2000 and 
10415W 10415Y 10515P
CPT2000 kits facilitate connection to, and delivery of, either 
11015L 11115K 11215U
contrast or saline into the patient via a coronary catheter (not  11315M 11715J 11815G
provided by ACIST). To be used for the controlled infusion of  11915D 12415J 12615P
radiopaque contrast media for angiographic procedures
13115M 13415W 13815G

Class II

Reports related to ingress of air
into the manifold.

13915T 14015P 14115M
14615D 14615M 15415G
15715D 16115H 16315L
16515E 16615Z 16815J 16915N
17115F 17615U 17815F 18215J
18415D 18515N 18715U
18815K 18915P 19015N
19115H 19315D 19415P
19515X 19715G 19815M
19915D 20115M 20315E
20715D 20815M 20915X
21115W 21815J 21815U
22015D 23715D 23815D
23815P 24415P 24615U
25015D 25515D 26415N
26715F 26815J 26815K 27115L
27215U 27315Z 27415H
27515D 29115D 29915E
29915F 30015E 30015F
32115M 32715G 32715V
32815M

Acist Medical
Systems

Emergency Transport Ventilator Oxylog 2000 Plus Ventilator  All Oxylog 2000 plus Ventilators
Catalog Number: 5705080. Volume controlled emergency and  with the identified catalog
numbers distributed between
transport ventilator with pressure support.

Class I

Devices

Emergency Transport Ventilator Oxylog 3000 Ventilator and 
Oxylog 3000 plus Ventilator Catalog Numbers: 
2M86300/2M86965 and 5704813/5704831. Volume 
controlled and pressure‐controlled emergency and transport 
ventilators.

Class I

Devices

Denali Filter‐Jugular/Subclavian DL950J Denali Filter‐Femoral  Product Code: DL950J Lot
Number: GFYA3093,
Delivery DL950F. Intravascular filters.

Devices

April 2007 - December 2015.

Devices

All Oxylog 3000 Ventilators and
Oxylog 3000 Plus Ventilators
with the identified catalog
numbers distributed between
April 2007 - December 2015.

GFYC3745, GFYD2734,
GFYF3878, GFYF3879,
GFYG3877, GFYG3880,
GFYI2699 Product Code:
DL950F Lot Number:
GFYA3093, GFYC3745,
GFYD2734, GFYF3878,
GFYF3879, GFYG3877,
GFYG3880 GFYI2699
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL  All Lots

Class II

Radiometer America
Inc

Customer complaints identified
and internal testing confirmed
that HemoslL Plasminogen Lot
N0455811 is not meeting labeled
on-board instrument stability
claims of 5 days.
The affected Small Electric Drive
(SED) may operate solely in
reverse mode, not operate in
reverse mode when intended,
not function, or unintentionally
start.
Damage to package seals
potentially compromising
sterility.

Instrumentation
Laboratory Co.

Class II

Devices

ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 
10310292 (100 test kit) and Catalog Number: 02676506/SMN 
10310293 (500 test kit) Product Usage: This in vitro diagnostic 
assay is intended to quantitatively measure prostate‐specific 
Antigen (PSA) in human serum using the ADVIA 
Centaur/XP/XPT/CP Systems.

Class II

Class II

Streptokinase reagent and 2 x 2 mL Chromogenic substrate

Synthes Small Electric Drive (SED). For use in general 
traumatology.

Devices

PS‐500 Scope Warmer; 10 units per box. Pre‐heating scope for  Lot# G154341 Exp: 4/14/18
laparoscopy surgery.

All Lots

Bard Peripheral
Vascular Inc

The AQURE System has a
design error regarding sample
type in which sample type may
be specified for some results
and left blank for other results.
The fact that the sample type
field is left blank in some cases
could lead to misinterpretation of
results
PSA assay is not meeting the
High Dose Hook Effect
expectation in the Instructions
for Use (IFU).

AQURE System; Model Number: 933‐599. The AQURE System  Model Number: 933-599 Version
1.8.3
manages blood gas and immunoassay analyzers.

Devices

Draeger Medical,
Inc.

Baxter Healthcare has issued an Baxter Corporation
Urgent Product Recall
Englewood
communication for all lots of
RAPIDFILL Syringe Strips due to
lack of evidence supporting the
packaging claim for 12-month
shelf life on released product.

Devices

Devices

Draeger Medical,
Inc.

Class II

Automated Syringe Filler (ASF)

SMN 10310292-100 test kits
Lot# UDI # 54637263
00630414203003546372631602
23 55304263
00630414203003553042631602
23 56249264
00630414203003562492641603
27 76727264
00630414203003767272641603
27 00825265
00630414203003008252651604
24 92416265
00630414203003924162651604
24 99151265
00630414203003991512651604
24 12970266
00630414203003129702661607
21 14158266
00630414203003141582661607
21 23016266
00630414203003230162661607
21 28881266
00630414203003288812661607
21 40776268
00630414203003407762681609
22 SMN 10310293-500 test kits
Lot# UDI # 54448263
00630414202990544482631602
23 55171263
00630414202990551712631602
23 56171264
Lot No. N0455811, Expiration
HemosIL Plasminogen, Part No. 0020009000, IVD. 
Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL  Date 03/31/2017

Drager became aware of
situations where the error
message "Poti unplugged" was
generated causing acoustic and
visual alarms, the breathing
system releases pressure and
the ventilation function stops
operating
Drager became aware of
situations where the error
message "Poti unplugged" was
generated causing acoustic and
visual alarms, the breathing
system releases pressure and
the ventilation function stops
operating.
IFU missing contraindications:
Patients with uncontrolled sepsis
and Patients with known
hypersensitivity to nickeltitanium alloys.

Class II

Class II

Siemens Healthcare
Diagnostics, Inc

The Anspach Effort,
Inc.

JosNoe Medical, Inc.


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