JANUARY 2006

WEEK ENDING JANUARY 7

PRODUCT
a) Insulin Pump, Model R1000,
b) Insulin Pump, Model IR1000,
c) Insulin Pump, Model IR1200,
d) Insulin Pump, Model IR1250,
CODE
a) Serial numbers: 07856-10, 22-09127-10;
b) Serial numbers: 06003-10, 31-04891-11;
c) Serial numbers: 08472-10, 88-06100-10;
d) Serial numbers: 26-07356-10, 90-14159-01
RECALLING FIRM/MANUFACTURER Animas Corporation, West Chester, PA
REASON Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure.
VOLUME OF PRODUCT IN COMMERCE 32 pumps
DISTRIBUTION Nationwide

PRODUCT
a) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000,
b) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001
c) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002
d) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003
e) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4005
f) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006
g) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4007
h) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008
i) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4009
j) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4010
k) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011
CODE
a) Lot numbers: 065021 and 085031;
b) Lot numbers: 045036, 065022, and 085032;
c) Lot numbers: 045037 and 065139;
d) Lot numbers: 045038 and 065140;
e) Lot numbers: 035194, 055030, and 065142;
f) Lot numbers: 045172 and 075112;
g) Lot numbers: 045173 and 075113;
h) Lot numbers: 085146 & 065143;
i) Lot numbers: 045175, 065144 and 085147;
j) Lot numbers: 035293, 055031 and 075114;
k) Lot numbers: 035196, 055032, and 075115
RECALLING FIRM/MANUFACTURER Dakocytomation California, Inc., Carpinteria, CA
REASON This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
VOLUME OF PRODUCT IN COMMERCE 5,270 units
DISTRIBUTION Nationwide and Internationally

PRODUCT 0.10% BreathScan Alcohol Detector. Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box
CODE D121898
RECALLING FIRM/MANUFACTURER
Recalling Firm: WNCK, Inc, The Woodlands, TX
Manufacturer: James Alexander Corporation, Blairstown, NJ.
REASON Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
VOLUME OF PRODUCT IN COMMERCE 126,552 units
DISTRIBUTION Nationwide, Canada and Israel

PRODUCT
a) Digital Radiography System Model DFP8000D
b) Digital Radiography System, Model DFP-8000D/FPD,
CODE
a) Serial Numbers: A3622068 A4512074 A3582042 A3542012 A4512073 A3552017 A4552098 A3622065 A3622066 A4542090 A3592048 B4602125 B4612134 B5512155 B4582116 W1B0542168 A3572018 A4562102 A35B2041 B4612132 A3542011 A3582037 A3622069 B4622149 B4602129 A3542006 B4612133 A3572032 A3522002 B4622146 A3542008 A3602050 A4512076 A4522079 A4522081 B4622150 B5522162 A3592046 A3532005 A3612057 A4572109 A3517002 B4622148 A4562099 A3612061 A4562101 B4612137 A3602055 A4542092 B5512154 A4542088 A3572030 A3582035 A3522004 A3562022 A3582036 B4622151 A3582013 A3582013 A45721 07 B4612141 A3517003 A4522080 A3522001 W180542173;
b) Serial Numbers: B5522165 B4592121 B4602124 B4602126 W1B0542172 W1B0542174 B4582115 B4622147 B4572111 B5522161 B5512160 A4562105 B4582113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys, Inc., Tustin, CA
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. .
REASON To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
VOLUME OF PRODUCT IN COMMERCE 85 units
DISTRIBUTION Nationwide

PRODUCT Disposable Tips 1000 µl with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1, Part Number 10612523, Blister 1 x 96 pcs.
CODE Lot No. U122098L-1325, Lot No. U122098L-3225 and Lot No. U122098L-2325.
The sub-lot numbers (i.e. 1325, 3225 and 2325) are printed on each blister and stamped in blue color on the shipping container in the upper right corner of the box.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tecan US, Inc, Research Triangle Park, NC
Manufacturer: Eppendorf Ag, Hamburg, Germany.
REASON Double filtering of 1000 µl tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.
VOLUME OF PRODUCT IN COMMERCE 3,000 Tips
DISTRIBUTION IL and Europe

PRODUCT HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads, Model M3717A
CODE Lot number: Y042005-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover, MA,
Manufacturer: Katecho Inc., Des Moines, IA.
REASON The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector.
VOLUME OF PRODUCT IN COMMERCE 253 cases (5/cs)
DISTRIBUTION Nationwide and Internationally

PRODUCT OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter)
CODE Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America, Inc, Irving, TX.
Manufacturer: Olympus Diagnostica Lab-Automation Gmbh, Freiburg, Germany.
REASON Lab Automation System may dilute samples with water.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Nationwide

PRODUCT
a) Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7", 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter,
b) Baxter Minivolume Extension Set, 72", product code 2C5687; An Rx sterile, nonpyrogenic fluid pathway, 72", 1.6 mL Vol., with a male Luer Lock adapter
c) Baxter Minivolume Extension Set, 36”, product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway, 36”, 0.9 mL Vol., with a male Luer Lock adapter
d) Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyrogenic fluid
pathway, 61”, 0.5 mL Vol., with Luer Lock adapters
e) Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60", product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60", 1.2 mL Vol.,with Luer Lock adapters
f) Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96", product code 2C9206; An Rx sterile,
nonpyrogenic fluid pathway, 96", 1.6 mL Vol., with Luer Lock adapters
g) Baxter Tamper Resistant Anti-Siphon Combination Set, 101”, product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101”, 2.5 mL Vol., with male Luer Lock adapter,
h) Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61", 1.4 mL Vol., with Luer Lock adapters,
i) Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile, nonpyrogenic fluid pathway with Needle Gauge 22, Needle Length ¾”, Total Volume 0.40 mL,
Total Length 9"
j) Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 3/4",
Total Volume 0.75 mL, Total Length 10",
k) Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length
¾”, Total Volume 0.75 mL, Total Length 10"
l) Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length
¾”, Total Volume 0.75 mL, Total Length 10"
m) Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle
Length 1", Total Volume 0.75 mL, Total Length 10"
n) Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1",
Total Volume 0.75 mL, Total Length 10",
o) Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1”,
Total Volume 0.70 mL, Total Length 10",
p) Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length
1-1/2”, Total Volume 0.75 mL, Total Length 10"
CODE
a) Lot numbers: UR247189, UR268656, UR268920, UR270256; extended to include lot numbers:UR255919 and UR261560;
b) Lot numbers: UE107920, UE108480, UE108696, UE108704, UE108977, UE108985; extended to include lots UE107680, UE107763, UE108035, UE108043, UE108050, UE108100, UE108282, UE108142, UE108233, UE108399, UE109355, UE109157;
c) Lot numbers: UE107936, UE108019, UE108712, UE109140; extended to include lots UE107722, UE108068, UE108092, UE108209, UE108308, UE108316, UE108332, UE108381;
d) Lot UR249987; extended to include lots UR244434, UR260422, UR270702;
e) Lot UR251058, extended to include lots UR257535, UR267369, UR274811, UR278069;
f) Lot numbers: UR254185, UR254524, UR273987; extended to include lot UR267344;
g) Lot numbers: UR251389, UR272328, UR272781, UR274704; extended to include lotsUR245704, UR269290, UR277616;
h) Lot numbers: UR266387, UR277061, UR277848; extended to include Lot numbers UR245662, UR253435, UR260398, UR255539, UR255992, UR259721, UR270793, UR280834;
i) Lot numbers: FC04055, FC05013; extended to include lot FC05026;
j) Lot numbers: FC04057, FC05001, FC05010, FC05017; extended to include lot numbers: FC04049,
FC05022, FC05027, FC05032;
k) Lot numbers: FC04053, FC05000, FC05005, FC05012; extended to include lot numbers: FC05016,
FC05028;
l) Lot numbers: FC04052, FC04058, FC04059, FC05006, FC05009; extended to include lot numbers: FC05018, FC05023, FC05029;
m) Lot numbers: FC04050, FC05007, FC05014; extended to include lots FC05020, FC05024, FC05030;
n) Lot numbers: FC04054, FC05003, FC05021; extended to include Lot numbers: FC05015, FC05033;
o) Lot numbers: FC04056, FC05004, FC05011; extended to include lot numbers: FC04047, FC04051, FC05025, FC05031;
p) Lot number: FC05002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR.
REASON The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
VOLUME OF PRODUCT IN COMMERCE 507,309 sets
DISTRIBUTION Nationwide and Internationally

PRODUCT Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
CODE Revision G (instrument not tracked by lot number).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encore Medical, Lp, Austin, TX
Manufacturer: Gauthier Biomedical Inc, Grafton, WI.
REASON Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
VOLUME OF PRODUCT IN COMMERCE 141 units
DISTRIBUTION Nationwide, Saudi Arabia, Japan and Germany

PRODUCT
a) Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement,
b) Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement,
CODE
a) Lot #426142 and #426132;
b) Lot #434322
RECALLING FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
VOLUME OF PRODUCT IN COMMERCE 30 total units
DISTRIBUTION AZ, CA, FL, GA, MO, NJ, OK, SC, SD, TX. and Germany

PRODUCT 3D TOP Ceiling Stand. X-Ray System model number 8773673
CODE All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA
Manufacturer: Siemens Medical Solutions, Forchheim, Germany.
REASON Screws on the rollers may become loose.
VOLUME OF PRODUCT IN COMMERCE 460 units
DISTRIBUTION Nationwide

PRODUCT Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585,
CODE Lot numbers: 044250, 134170, 781690, 781700, 838920, 914620 and 914630.
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN
REASON The bit may bend or fracture during use.
VOLUME OF PRODUCT IN COMMERCE 46 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482
CODE Lot numbers: M05J0371, M05E0548
RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN
REASON Screwdriver handle breakage.
VOLUME OF PRODUCT IN COMMERCE 75 units
DISTRIBUTION IL, IN, MI, CA, Japan, and the Netherlands

PRODUCT
a) Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
b) Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
CODE a) and b) Lot Number: 5LU319
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care North America, Lexington, MA
Manufacturer: Fresenius Medical Care North America, Ogden, UT.
REASON Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
VOLUME OF PRODUCT IN COMMERCE 1136 cases
DISTRIBUTION Nationwide

PRODUCT
a) McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number: 468-380,
b) McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number: 163-360,
CODE
a) Lot# 1121360, Serial# 11567825, 11567826, 11567827, 11567828, 11567829, 11567830,
11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841,
11567842, & 11567843;
b) Lot#1121514, Serial# 11567927 & 11567935
RECALLING FIRM/MANUFACTURER Inamed Corp, Goleta, CA
REASON Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
VOLUME OF PRODUCT IN COMMERCE 20 units
DISTRIBUTION Nationwide

Roche Diagnostics Issues a Worldwide Voluntary Recall of Some of its ACCU-CHEK® Aviva Meters

Roche Diagnostics has initiated a worldwide voluntary recall of specific ACCU-CHEK Aviva Meters because of the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used.

The recall includes U.S. serial numbers 52500000000 through 52510999999. In the U.S. people with diabetes, health care professionals, pharmacists, and distributors have been instructed that if they have a meter with these serial numbers, they should contact 1-888-591-5084 for a product replacement. The recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips. This information is also available on the ACCU-CHEK website at http://www.accu-chek.com/.

Outside the U.S., the recall includes serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999, and 52800000000 through 52810999999.

In the U.S., consumers with general questions may contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 and health care professionals may contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638.

PRODUCT Vitros Immunodiagnostic HbsAg Confirmatory Kit 8 Ref 680 1324, UPC +H221680132412. Each kit contains: 1 x kit of reagents, and protocol card for HbsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.
CODE Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK.
REASON Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as “Not Confirmed”.
VOLUME OF PRODUCT IN COMMERCE 436 kits
DISTRIBUTION Nationwide, PR and the Caribbean

PRODUCT NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
CODE W050708, W050980, & W050997
RECALLING FIRM/MANUFACTURER Integra Neuro Sciences, San Diego, CA
REASON Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to ± 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of ± 2 mmHg maximum ICP drift within the first 24 hours of monitoring.
VOLUME OF PRODUCT IN COMMERCE 79 kits
DISTRIBUTION Nationwide

PRODUCT
a) Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050.
b) Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0.
c) Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO,
d) Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone
Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0,
e) Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F
Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO,
CODE
a) 1007398, 1017115, 1018449;
b) 1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952;
c) 1009522, 1009825, 1012337, 1013926, 1017134, 1017763, 1018161, 1018456, 1022953;
d) 1011815, 1020902, 1021341, 1021634;
e) 1012596, 1020903
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp, Natick, MA
Manufacturer: Boston Scientific Corp, Glens Falls, NY.
REASON Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
VOLUME OF PRODUCT IN COMMERCE Nationwide: 1,041 units; Internationally: 293 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Introducer Set. Labeled as "Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)" Catalog # 06607 (Oscor) and 666089-201 (Guidant),
CODE BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
RECALLING FIRM/MANUFACTURER Oscor, Inc., Palm Harbor, FL
REASON Sheath size is larger than dilator size causing insertion difficulties.
VOLUME OF PRODUCT IN COMMERCE 6,985 sets
DISTRIBUTION Nationwide and Internationally

PRODUCT 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton
CODE Lot numbers 60710907 and 60710908
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA,
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ.
REASON Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
VOLUME OF PRODUCT IN COMMERCE 8,000 units
DISTRIBUTION The product was shipped to two consignees that repack the product into their own kits. The OEM customers conducted recalls of the finished product.

PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA, product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., McGaw Park, IL,
Manufacturer: Baxter Healthcare Corp., Largo, FL.
REASON Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.
VOLUME OF PRODUCT IN COMMERCE 29,173 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
A) IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable, Catalog Number IN1600,
b) IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable,
Catalog Number IN1600/A,
c) IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Catalog Number IN1615,
d) IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Catalog Number IN1615/A,
CODE
a) Serial Numbers: T2370-0004, T2370-0007, T2370-0013, T2370-0014, T2370-0018, T2370-0019, T2370-0021, T2370-0023, T2370-0029, T2370-0030, T2370-0031, T2370-0032, T2370-0034, T2370-0041, T2370-0043, T2370-0044, T2370-0045, T2370-0047, T2370-0048, T2370-0049,
T2370-0050, T2370-0059, T2370-0063, T2370-0064, T2370-0074, T2482-0029;
b) Serial Numbers: T2370-0008, T2370-0009, T2370-0011, T2370-0016, T2370-0017, T2482-0037, T2370-0039, T2370-0040, T2370-0042, T2370-0051, T2370-0054, T2370-0056, T2370-0060, T2370-0065, T2482-0002, T2482-0025, T2482-0034, T2482-0046, T2482-0049, T2482-0055,
T2482-0058, T2482-0068, T2482-0069, T2482-0071, T2482-0073, T2482-00078, T2482-0081, T2482-0084, T2482-0085, T2482-0089, T2482-0091, T2482-0094, T2483A-0018, T2483A-0019, T2483A-0022;
c) Serial Numbers: T2370-0025, T2370-0035, T2370-0037, T2370-0046, T2370-0053, T2370-0057, T2370-0058, T2370-0068, T2370-0069, T2370-0071, T2370-0072, T2370-0073, T2370-0075, T2370-0076, T2370-0077, T2370-0078, T2482-0013, T2482--0020, T2482-0030, T2482-0032,
T2482-0035, T2482-0041, T2482-0043, T2482-0065;
d) Serial Numbers: T2482-0005, T2482-0006, T2482-0009, T2482-0010, T2482-0017, T2482-0018, T2483A-0025, T2483A-0026, T2482-0028, T2482-0033, T2482-0048, T2482-0050, T2482-0056, T2482-0059, T2482-0064, T2482-0070, T2482-0074, T2482-0076, T2482-0080, T2482-0082,
T2482-0086, T2482-0087, T2482-0090, T2482-0093, T2483A-0004, T2483A-0015, T2483A-0023, T2483A-0032, T2483A-0037, T2483A-0042, T2483A-0046, T2483A-0074, T2483A-0080, T2483A-0081, T2483-0082, T2483A-0094, T2483A-0095, T2483A-0100
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT
REASON Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
VOLUME OF PRODUCT IN COMMERCE 123 units
DISTRIBUTION Nationwide and Internationally

PRODUCT ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa’s computed radiography product line
CODE Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC,
Manufacturer: AGFA, Corp, Mortsel, Belgium.
REASON Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
VOLUME OF PRODUCT IN COMMERCE 1,059 units
DISTRIBUTION Nationwide

PRODUCT CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
CODE Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC
Manufacturer: AGFA, Corp, Mortsel, Belgium.
REASON Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
VOLUME OF PRODUCT IN COMMERCE 2,630 units
DISTRIBUTION Nationwide

PRODUCT The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT
CODE Domestic Distribution Serial Numbers: VS4700581, VS4700661, VS4700631, VS4702578, VS4702507, VS4702551, VS4702583, VS4702589, VS4702590, VS470259], VS4702574, VS4702580, VS4702566, VS4700824, VS4702593, VS4700835, VS4700536, 1VS4700539, VS4700540, VS4700543, VS4700544, S4700546, VS4700548, VS4700549, VS4700550, VS4700552,VS4700554, VS4700555, VS4700558, VS4700565, VS4700566,VS4700567, VS4700569, VS4700573, VS4700574, VS4700577,VS4700578, VS4700580, VS4700581, VS4700585, VS4700588VS4700590, VS4700593, VS4700594, VS4700595, VS4700596, VS4700605, VS4700607, VS4700608, VS4700613, VS4700614, VS4700615, VS4700617, VS4700620, VS4700622, VS4700624, VS4700625, VS4700632, VS4700635, VS4700637, VS4700642, VS4700643, VS4700646, VS4700647, VS4700649, VS4700650, VS4700653, VS4700660, VS4700661, VS4700663, VS4700668, VS4700670, VS4700673, VS4700681, VS4700687, VS4700693, VS4700694, VS4700698, VS4700699, VS4700708, VS470071O, VS4700711, VS4700718, VS4700719, VS4700721, VS4700724, VS4700725, VS4700729, VS4700730, VS4700736, VS4700738, VS4700739, VS4700740, VS4700743, VS4700744, VS4700750, VS4700751, VS4700754, VS4700760, VS4700761, VS4700762, VS4700767, VS4700770, VS4700772, VS4700773, VS4700774, VS4700775, VS4700776, VS4700777, VS4700780, VS4700781, VS4700782, VS4700783, VS4700785, VS4700786, VS4700789, VS4700790, VS4700791, VS4700796, VS4700797, VS4700798, VS4700802, VS4700804, VS4700808, VS4700809, VS4700811, VS4700813, VS4700814, VS4700816, VS4700817, VS4700818, VS4700819, VS4700821, VS4700822, VS4700823, VS4700827, VS4700828, VS4700829, VS4700832, VS4700833, VS4700834, VS4700836, VS4700837, VS4700838, VS4700840, VS4700841, VS4700842, VS4700843, VS4700844, VS4700846, VS4700847, VS4700849, VS4700850, VS4700852, VS4700853, VS4700854, VS4700855, VS4700856, VS4702501, VS4702502, VS4702505, VS4702512, VS4702516, VS4702519, VS4702523, VS4702524, VS4702525, VS4702528, VS4702531, VS4702532, VS4702535, VS4702543, VS4702544, VS4702545, VS4702548, VS4702549, VS4702552, VS4702553, VS4702555, VS4702556, VS4702557, VS4702567, VS4702568, VS4702570, VS4702571, VS4702572, VS4702573, VS4702575, VS4702586, VS4702594, VS4702599, VS4702600, VS4702604, VS4702612, VS4702613, VS4702623, VS4702636, VS4702647, VS4702650, VS4702670, VS4702677, VS4702688, VS4702689, VS4702709, VS4702734, VS4702747, VS4702748, VS4702750, VS4702776, VS4702784, VS4702800, VS4702805, VS4702809, VS4702811, VS4702813, VS4702825, VS4702835, VS4702848, VS4702854, VS4702856, VS4702857, VS4702859, VS4702883, VS4702885, VS4702981, VS4703079, VS4703103 International Distribution Serial Numbers: VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4700792, VS4702722, VS4700563, VS4700696, VS4700820, VS4700601, VS4702645, VS4700839, VS4700644, VS4700589, VS4700703, VS4700723, VS4700746, VS4700553, VS4700628, VS4702962, VS4702983, VS4702995, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4700717, VS4700645, VS4702915, VS4702500, VS4702828, VS4702858
RECALLING FIRM/MANUFACTURER Respironics California, Inc., Carlsbad, CA
REASON During product testing of the PLY Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.
VOLUME OF PRODUCT IN COMMERCE 268 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optional Retractable Beam Shield
CODE Serial numbers: 1941, 1944, 1953, 1991, 2014, 2029, 2093, 2111, 2113, 2163, 2182, 2238, 2281, 2295, 2329, 2389, 2407, 2429, 2431, 2435, 2443, 2455, 2471, 2486, 2487, 2489, 2495, 2497, 2504, 2527, 2549, 2553, 2557, 2558, 2572, 2586, 2594, 2603, 2605, 2607, 2635, 2637, 2642, 2653, 2675, 2689, 2699, 2712, 2728, 2731, 2736, 2737, 2744, 2746, 2772, 2793, 2795, 2805, 2809, 2843, 2845, 2853, 2865, 2873, 2879, 2926, 2942, 2946, 2949, 2969, 2972, 2976, 3007, 3138, 3152, 3157, 3167, 3184, 3187, 3196, 3247, 3286, 3325, 3337, 3352, 3379, 3439, 3442, 3463, 3512, 3527, 3528, 3532, 3535, 3538, 3559, 3647, 3648, 3652, 3664, 3674, 2174, 2176, 2178, 2187, 2188, 2209, 2215, 2253, 2259, 2266, 2285, 2296, 2298, 2303, 2308, 2356, 2359, 2365, 2377, 2381, 2386, 2409, 2416
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA
REASON Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
VOLUME OF PRODUCT IN COMMERCE 125 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Schuster Anorectal Manometry Probe. Labeling applied to the balloon pouch reads in part: "SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric
Manometry Balloon Probe P/N: A86-4050. *** Size: Adult ... CAUTION: Balloons are made of latex rubber. *** Do not use if latex sensitivity exists.” Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free***, Product model # A86-4050,
b) Schuster Anorectal Manometry Probe. Labeling applied to the balloon pouch reads in part: "SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe P/N: A86-5050. *** Size: Pediatric...CAUTION: Balloons are made of latex rubber. *** Do not use if latex sensitivity exists." Additional labeling found on the pouch reads
in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Product model # A86-5050
CODE a) and b) All lot numbers;
RECALLING FIRM/MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, CO
REASON The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.
VOLUME OF PRODUCT IN COMMERCE 4,342 probes
DISTRIBUTION Nationwide, Egypt, and the Netherlands

PRODUCT Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
CODE 4397, 5257, 4176, 1052, 4222, 4064, 5024, 4009, 4241, 5313, 1139, 5484, 4328, 5201, 5246, 5381, 4296, 4258, 5277, 4246, 1240, 5297, 5311, 5434, 5512, 506, 4207, 1072, 4089, 5373, 1014, 1078, 4025, 5551, 4131, 5455, 5328, 5379, 5261, 4416, 4206, 1191, 4088, 5195, 5334, 5451, 4383, 5250, 5309, 5342, 4183, 4272, 5268, 5009, 4047, 4254, 4261, 5307, 4102, 5199, 5558, 5315, 5266, 5303, 1061, 4307, 5390, 4267, 4386, 5282, 1113, 5123, 5501, 1062, 4339, 5383, 5478, 5507, 4162, 1015, 5162, 1081, 4170, 5477, 4322, 5515, 4069, 5081, 4201, 354, 5345, 4374, 4146, 1097, 5519, 5314
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands.
REASON The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.
VOLUME OF PRODUCT IN COMMERCE 96 units
DISTRIBUTION Nationwide

PRODUCT Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number.
CODE All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050
RECALLING FIRM/MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, CO
REASON Labeling does not indicate that the product contains latex.
VOLUME OF PRODUCT IN COMMERCE 2,358 Probes
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001
b) Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001
c) Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001
CODE All units with Co-Oximetry (COOX) modules
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN
Manufacturer: Roche Diagnostics GmbH, Graz, Austria.
REASON Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb or HHb.
VOLUME OF PRODUCT IN COMMERCE 35 units
DISTRIBUTION Nationwide

PRODUCT LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm’s linear accelerator used to deliver radiation therapy to cancer patients. The MedOnc module is distributed by Siemens Medical Solutions USA - Oncology Division, with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
CODE Serial #: 93-0001, 93-0016, 93-0027, 93-0289, 93-0304, 93-0306, 93-0333, 93-0368, 93-0430, 93-0436, 93-0549, 93-0639, 93-0641, 93-0652, 93-0664, 93-0703, 93-0718 and 93-0786
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA
Manufacturer: Impac Medical Systems, Inc., Mountain View, CA.
REASON When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in patients less than two years old to be seriously overdosed with radiation.
VOLUME OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70
CODE Lot G653628
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN
REASON The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
VOLUME OF PRODUCT IN COMMERCE 11
DISTRIBUTION CA, IN, and NC

Use: The Vapotherm 2000i and 2000h Respiratory Gas Administration delivers moisture to and warms breathing gases through a flexible nasal tube for patients receiving supplemental oxygen. The environments of use include home, hospital or sub-acute institutional settings.

Reason for Recall: Reports of Vapotherm units becoming contaminated with Ralstonia spp, and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis (infection of the trachea), sepsis (infection in the bloodstream), pneumonia (lung infection), or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborns could develop pneumonia, sepsis and in the most severe cases, death.

Public Contact: David Lain
Chief Regulatory Officer
Vapotherm, Inc.
198 Log Canoe Circle
Stevensville, MD 21012
410-604-3977

PRODUCT Vapotherm™ Respiratory Gas Humidifier, Model 2000i,
CODE All S/Ns of the Vapotherm™ Model 2000i are affected
RECALLING FIRM/MANUFACTURER Vapotherm, Inc, Stevensville, MD
REASON Vapotherm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.
VOLUME OF PRODUCT IN COMMERCE 5,092 units
DISTRIBUTION Nationwide

PRODUCT Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System
CODE All serial numbers and lot codes are affected
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN
Manufacturer: Medtronic Puerto Rico Inc., Villalba, PR.
REASON A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. To maintain the intended tissue heating safety margin, the recommended maximum displayed head SAR is now 0.1 W/kg.
VOLUME OF PRODUCT IN COMMERCE 149,656 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference number: 7210430,
CODE Lot number: 50102446
RECALLING FIRM/MANUFACTURER Smith & Nephew Inc., Endoscopy Division, Mansfield, MA
REASON Drill does not contain laser etched depth marks to assure proper depth of inserted device.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION NC and PR

PRODUCT BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder
CODE Catalog # -- Lot #: 367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ
Manufacturer: Becton Dickinson Preanalytical Solutions, Sumter, SC.
REASON Cracked finger grip luer adapter components on the Push Button Blood Collection Set.
VOLUME OF PRODUCT IN COMMERCE 118,200 units
DISTRIBUTION Nationwide

PRODUCT
a) Kimberly-Clark/Ballard TRACH CARE* -72 Closed Suction products for Adults, Rx Only,
Sterile * Diameter 14 Fr (4.6 mm), 54 cm(21.3 in) * Single Use * Made in Mexico, Catalog number 227, b) Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use, Catalog number 8308
c) Kimberly-Clark/Ballard TRACH CARE Wet Pack *Y Adapter * Closed Suction System for Neonates
* Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) *Single Use,
CODE
a) Lot number: 317128 and 317129;
b) Lot number: 318065;
c) Lot number: 309962
RECALLING FIRM/MANUFACTURER Kimberly-Clark Corporation, Roswell, GA
REASON The integrity of the sterile unit package may become compromised.
VOLUME OF PRODUCT IN COMMERCE 869 cases (20 units per case)
DISTRIBUTION Nationwide

PRODUCT
a) Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No.M00516401.
b) Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501
CODE
a) Lot numbers: 7669915, 7731928, 7809849 and 7580900;
b) Lots 7579586, 7605110, 7606870, 7606871, 7630518, 7630517, 7628255, 7650452, 7646613,
7664540, 7664221, 7661326, 7668106, 7713491, 7697308, 7701032, 7697695, 7731922, 7730456,
7713492, 7731923, 7750676, 7750675, 7750674, 7766684, 7766527, 7790329, 7769605, 7798015,
7799940, 7807535, 7809850, 7825637, 7825638, 7828001, 7854861, 7853825, 7856736, 7860774,
7874570, 7880712, 7899057, 7898228, 7886786, 7933144, 7929889, 7923394, 7924985 and 7949015
RECALLING FIRM/MANUFACTURER Boston Scientific Corp, Spencer, IN
REASON The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
VOLUME OF PRODUCT IN COMMERCE 12,930
DISTRIBUTION Nationwide and Internationally

PRODUCT GEM PREMIER 3000, Point-of-care blood analyzer.
CODE Serial numbers starting with 18412
RECALLING FIRM/MANUFACTURER Instrumentation Laboratory Co., Lexington, MA
REASON Software error may report higher results for glucose and lactate.
VOLUME OF PRODUCT IN COMMERCE 2,021 units
DISTRIBUTION Nationwide and Canada

PRODUCT Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637
CODE CXP Cytometer Software Version 2.0 (acquisition software only).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA
Manufacturer: Applied Cytometry Systems, Dinnington, United Kingdom.
REASON Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0.
VOLUME OF PRODUCT IN COMMERCE 179
DISTRIBUTION Nationwide and Canada

PRODUCT
a) GE LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477,
b) GE LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI
Manufacturer: General Electric Med Systems China Co., Ltd., Wuxi, Jiangsu, China.
REASON The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.
VOLUME OF PRODUCT IN COMMERCE 3,091 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR
CODE Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur, Reykjavik, Ireland
Manufacturer: Ossur North America Inc., Aliso Viejo, CA.
REASON After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.
VOLUME OF PRODUCT IN COMMERCE 48 units
DISTRIBUTION Nationwide

PRODUCT Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets
CODE List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump; List No. 12618-04 Plum A+3 I.V. Infusion Pump; List No. 12348-04 Plum A+3 I.V. Infusion Pump. List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04; 12348-04; 12348-04; 12391-13; 12391-1312391-1 12618-04. All serial numbers of the above list numbered product are included in this correction.
RECALLING FIRM/MANUFACTURER Hospira Inc, Morgan Hill, CA
REASON The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.
VOLUME OF PRODUCT IN COMMERCE 64,404 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Cook brand Zilver 635 Biliary Stent --Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-7.0-40.
b) Cook brand Zilver 635 Biliary Stent --Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60
CODE
a) Lot number: 1546123;
b) Lot number: 1544171
RECALLING FIRM/MANUFACTURER Cook Inc, Bloomington, IN
REASON The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
VOLUME OF PRODUCT IN COMMERCE 15
DISTRIBUTION CT, MI, MN, MT, NV, PA, UT, WI and Canada

PRODUCT Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53);
CODE H530338, H531026, H532001, H532024, H541335, H532011, H531018, H530104, H532027, H530309, H530321, H530323, H531034, H531995, H530204, H541198, H531038, H530427, H532036, H530313, H530250, H532025, H530064, H530009, H530093, H530311, H530042, H530231, H530316, H530084, H530065, H530022, H530029, H530340, H530302, H532023, H530059, H531037, H530396, H530080, H532038, H530333, H530408, H531024, H530032, H530025, H530414, H530051, H530052, H530310, H533006, H530324, H530419, H530056, H531040, H531043, H531033, H530086, H532028, H532010, H530433, H532035, H531044, H532020, H531039, H535018, H531017, H530078, H532002, H530406, H532019, H530334, H531002, H530019, H532031, H530107, H530066, H530075, H530417, H532015, H533001, H530001, H530018, H530033, H531036, H530402, H534223, H530017, H530011, H530434, H533020, H530074, H530428, H530339, H530425, H530031, H532026, H531031, H531001, H533035, H530050, H530024, H530439, H531470, H531487, H532032, H534015, H530039, H531838, H532022, H533018, H530437, H530030, H532006, H533008, H535009, H533015, H534021, H534022, H534032, H530061, H532037, H530028, H531010, H531028, H535012, H532039, H530013, H530073, H530330, H533030, H534004, H534040, H530085, H533027, H534036, H532005, H530430, H530435, H531029, H530023, H530035, H530036, H530037, H530038, H530045, H530049, H530063, H530126, H530401, H530409, H530410, H530429, H530441, H531020, H531021, H532042, H533036, H535001, H535008, H531035, H531041, H532014, H533004, H535003, H535004, H530014, H533014, H530012, H530021, H530337, H531023, H533037, H530004, H530008, H530027, H530047, H530055, H530068M, H530068R1, H530072, H531008, H532013, H533032, H530087, H533028, H533029, H534026, H535002, H535013, H531025, H532021, H534020, H530081, H532007, H530057, H530076, H533043, H530043, H530405, H531042, H531345, H532004, H532016, H530052, H530104, H530402, H530427, H531044, H530034, H530218, H535015, H530048, H530423, H530005, H530046, H532029, H530319, H535005
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Palo Alto, CA
REASON The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment. If the treatment plan called for multiple MLC leaf positions then a mistreatment could occur, since the MLC leaves would not change as expected.
VOLUME OF PRODUCT IN COMMERCE 219 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60
b) Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80
c) Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D.
11.0mm length 130 mm; REF 67HA80,
CODE
a) Lot number: G706181;
b) Lot numbers: G711870 and G711871;
c) Lot number: G711880
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN
REASON Sterility is compromised by incomplete package seal.
VOLUME OF PRODUCT IN COMMERCE 178 units
DISTRIBUTION Nationwide and Canada

PRODUCT "iSite" PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
CODE All models, version 3.3
RECALLING FIRM/MANUFACTURER Stentor, Inc., Brisban, CA
REASON When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and diagnostic display screens.
VOLUME OF PRODUCT IN COMMERCE 110 units
DISTRIBUTION Nationwide

PRODUCT Milex 60cc Handy-Vak Locking Syringe Ref: MX500
CODE Lot number: 39608, Exp. Date April 08
RECALLING FIRM/MANUFACTURER CooperSurgical, Inc., Trumbull, CT
REASON Potential for the plunger to separate from the piston.
VOLUME OF PRODUCT IN COMMERCE 496 units
DISTRIBUTION CA, CO, HI, IL, MA, NH, PA, VA, WA and Canada

PRODUCT
a) BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle, Reference Number 305945: 1mL 27G Blister
b) D 1 mL BD Safety Glide Tuberculin syringewith 26 G x 3/8 in. BD needle, Reference Number 305946: Product Description: 1ml 26G Blister,
c) BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide. Reference Number 305950: Product Description: 1 mL 27G Allergist Tray,
d) BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide, Reference Number 305951: Product Description: 1 mL 26G Allergist tray,
CODE
a)Lot #: 5201851; 5201855; 5201853; 5175734; 5175732; 5175731; 5175730; 5146694; 5146689; 5146686; 5146691; 5146688; 5115764; 5111314; 5111313; 5082345; 5082341; 5082350; 5082344; 5052275; 5052276; 4344969; 4344970; 4344930; 4344978; 4344934; 4323196; 4323195; 4323194; 4296986;
b) Lot #: 5201856; 5175735; 5146697; 5143522; 5111315; 5082352; 5052279; 5020322; 4344951; 4323197;
c) Lot Number: 5167180; 5167183; 5111316; 5111317; 5082354; 5082355; 5052282; 5020329; 5020326; 4344954; 4344973; 4323198; 4323202;
d) Lot #: 5111318; 5082356; 5052286; 4344974; 4323204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ
Manufacturer: Becton Dickinson Medical - Diabetes Care, Holdrege, NB.
REASON Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
VOLUME OF PRODUCT IN COMMERCE 7,274,800 syringes
DISTRIBUTION Nationwide and Canada

PRODUCT BBL™ GasPak™ Pouch System and BBL™ GasPak™ CampyPouch™ System, Catalog numbers 260651 and 260656, packed in boxes of 25
CODE BBL™ GasPak™ Pouch System Batch Expiration Date 5214643 08/31/06 5214642 08/31/06 5214640 08/31/06 5194865 08/31/06 5194863 08/31/06 5189360 07/31/06 5189359 07/31/06 5189358 07/31/06 5189357 07/31/05 5189356 07/31/06 5189355 07/31/06 5189353 07/31/06 5182704 07/31/06 5182703 07/31/06 5182702 07/31/06 5182701 07/31/06 5165500 06/30/06 5165499 06/30/06 5165496 06/30/06 5165494 06/30/06 5165491 06/30/06 5158860 06/30/06 5154612 06/30/06 5154610 06/30/06 5152966 06/30/06 5152958 06/30/06 5146724 06/30/06 5126942 05/31/06 5119623 05/31/06 5119622 05/31/06 5119621 05/31/06 5119620 05/31/06 5119619 05/31/06 4345515 12/31/06 5097847 04/30/06 5097845 04/30/06 5097841 04/30/06 5097838 04/30/06 5097837 04/30/06 5074202 03/31/06 5074200 03/31/06 5074198 03/31/06 5069662 03/31/06 5069660 03/31/06 5069659 03/31/06 5061870 03/31/06 5061866 03/31/06 5056474 03/31/06 5056472 03/31/06 5056471 03/31/06 5052074 01/31/06 5052071 01/31/06 5052070 01/31/06 5048914 01/31/06 5040337 01/31/06 5040336 01/31/06 5035915 01/31/06 5035914 01/31/06 5032185 01/31/06 5032184 01/31/06 5031047 01/31/06 5031045 01/31/06 5028254 01/31/06 5021661 01/31/06 5019413 01/31/06 5019411 01/31/06 5013255 01/31/06 5013253 01/31/06 5010278 01/31/06 5010276 01/31/06 5010274 01/31/06 4365412 01/31/06 4355778 12/31/05 4355774 12/31/05 4355771 12/31/05 4352493 12/31/05 4345533 12/31/05 4345531 12/31/05 4345521 12/31/05 4345518 12/31/05 4345515 12/31/05 4343926 12/31/05 4343923 12/31/05 4343922 12/31/05 4341958 11/30/05 4338027 11/30/05 4338025 11/30/05 4338023 11/30/05 4324272 11/30/05 4324271 11/30/05 4324269 11/30/05 4324267 11/30/05 4316041 11/30/05 4316036 11/30/05 4316035 11/30/05 4316033 11/30/05 4316030 11/30/05 4316029 11/30/05 4315197 11/30/05 4315194 11/30/05 4315192 11/30/05 4303939 11/30/05 4303937 11/30/05 4303933 11/30/05 4303932 11/30/05 ***********************************************************BBL™ GasPak™ CampyPouch™ System Batch Expiration Date 5164299 8/31/2006 5158868 6/30/2006 5158867 6/30/2006 5158866 6/30/2006 5129239 5/31/2006 5126951 5/31/2006 5126949 5/31/2006 5126947 5/31/2006 5104863 4/30/2006 5104862 4/30/2006 5104859 4/30/2006 5063685 3/31/2006 5063687 3/31/2006 5063684 3/31/2006 5055069 3/31/2006 5048900 2/28/2006 5046481 2/28/2006 5046480 2/28/2006 5042726 2/28/2006 5042721 2/28/2006 5024692 1/31/2006 5024129 1/31/2006 5024120 1/31/2006 5024692 1/31/2006 4335944 12/31/2005 4335943 12/31/2005 4335938 12/31/2005 4335940 12/31/2005 4335932 12/31/2005 4335935 12/31/2005 4303906 11/30/2005 4303857 11/30/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD
Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR.
REASON Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.
VOLUME OF PRODUCT IN COMMERCE 61,647 boxes of 25 /box
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) 6 cm Catheter Reservoir with 10 cm extension,
b) 7 cm Catheter Reservoir with 10 cm extension,
c) 10 cm Scopable Catheter Reservoir,
CODE
a) M1475/PR06X/12-2009 and N0112/PR06X/03-2010;
b) M1330/PR07X/11-2009 and M1476/PR07X/12-2009;
c) N0297/SRS10/03-2009
RECALLING FIRM/MANUFACTURER Vygon Neuro, Norristown, PA
REASON Stylet in package is shorter than that claimed on the label.
VOLUME OF PRODUCT IN COMMERCE 70 units
DISTRIBUTION CA and Germany

PRODUCT Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038" (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038" end hole; Reorder # MWCE-38-20-20.
CODE Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN
REASON The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
VOLUME OF PRODUCT IN COMMERCE 242 units
DISTRIBUTION DE, NY and PA

PRODUCT Alsius CoolGard Temperature Regulation System
CODE Serial # 30000011 30000012 30000013 30000014 30000016 30000017 30000018 30000019 30000020 30000022 30000023 30000024 30000025 30000026 30000027 30000029 30000030 30000031 30000032 30000033 30000034 30000035 30000036 30000037 30000038 30000039 30000040 30000041 30000042 30000043 30000044 30000045 30000046 30000047 30000048 30000049 30000050 30000051 30000052 30000053 30000054 30000055 30000056 30000057 30000058 30000059 30000060 30000061 30000062 30000063 30000064 30000065 30000066 30000068 30000069 30000070 30000071 30000072 30000073 30000074 30000075 30000076 30000077 30000078 30000079 30000081 30000082 30000083 30000084 30000085 30000086 30000087 30000088 30000089 30000090 30000091 30000092 30000093 30000094 30000095 30000096 30000097 30000098 30000100 30000101 30000102 30000103 30000104 30000105 30000106 30000107 30000108 30000109 30000110 30000111 30000112 30000113 30000114 30000115 30000116 30000117 30000118 30000119 30000120 30000121 30000122 30000123 30000124 30000125 30000126 30000127 30000128 30000129 30000130 30000131 30000132 30000133 30000134 30000136 30000138 30000139 30000140 30000141 30000142 30000143 30000144 30000145 30000146 30000147 30000148 30000149 30000150 30000151 30000152 30000154 30000155 30000156 30000157 30000158 30000159 30000160 30000162 30000163 30000164 30000165 30000166 30000167 30000168 30000169 30000170 30000171 30000172 30000173 30000174 30000175 30000176 30000177 30000178 30000179 30000180 30000181 30000182 30000183 30000184 30000185 30000186 30000187 30000188 30000189 30000190 30000191 30000192 30000193 30000194 30000195 30000196 30000197 30000198 30000199 30000200 30000201 30000202 30000203 30000204 30000205 30000206 30000207 30000208 30000209 30000210 30000211 30000212 30000213 30000214 30000215 30000216 30000217 30000218 30000219 30000220 30000221 30000222 30000223 30000224 30000225 30000226 30000227 30000228 30000229 30000230 30000232 30000233 30000234 30000235 30000236 30000237 30000238 30000239 30000240 30000241 30000242 30000243 30000244 30000245 30000246 30000247 30000248 30000249
RECALLING FIRM/MANUFACTURER Alsius Corporation, Irvine, CA
REASON Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
VOLUME OF PRODUCT IN COMMERCE 239 units
DISTRIBUTION Nationwide and Internationally

PRODUCT V.A.C. ATS Canister with Gel (500 mL), Part # M6275063/10.S,
CODE Lot number: 081505806M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinetic Concepts, Inc., San Antonio, TX
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana, Mexico.
REASON Possible mislabeling of shipping cartons.
VOLUME OF PRODUCT IN COMMERCE 64 cartons, each containing 10 canisters
DISTRIBUTION Nationwide

PRODUCT
a) Roche Elecsys total PSA, catalog number 11731262322,
b) Roche Elecsys total PSA CalSet, catalog number 11731696322
CODE
a) Lot number: 171640;
b) Lot number: 171735
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN
Manufacturer: Roche Diagnostics GmbH, Penzberg, Germany.
REASON There is a possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
VOLUME OF PRODUCT IN COMMERCE 50,000 kits
DISTRIBUTION Nationwide

PRODUCT
a) Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
b) Clinical Chemistry Immunoglobulin M, List Number 1E01-20
c) Clinical Chemistry Prealbumin, List Number 1E02-20
CODE
a) Lot numbers: 30029HW00, 28002HW00, 26027HW00 and 23006HW00;
b) Lot numbers: 30067HW00, 27057HW00 and 23026HW00;
c) Lot numbers: 32063HW00, 27019HW00 and 23044HW00
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div., South Pasadena, CA
REASON These specific protein assays are not meeting the 57-day on board stability claim.
VOLUME OF PRODUCT IN COMMERCE 2,626 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141.
CODE Lot numbers: 571, 606, 695, 754, 952, 945, 1024, 1066
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Gastroenterology/Urology, Shoreview, MN
Manufacturer: Catheter and Disposables Technology, Inc., Plymouth, MN.
REASON Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.
VOLUME OF PRODUCT IN COMMERCE 140 catheters
DISTRIBUTION CA, CO, FL, MA, OH, PA, Finland, Italy and Portugal

PRODUCT VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
CODE PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland.
REASON The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happened during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
VOLUME OF PRODUCT IN COMMERCE 14 devices
DISTRIBUTION AZ, CA, CO, ID, NY, OK, TX, UT and WI

PRODUCT ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, CODE All lots/serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc, Irving, TX
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan.
REASON System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.
VOLUME OF PRODUCT IN COMMERCE 1,206 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Architect Stat Myoglobin Calibrators; List 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL,
CODE Lot number: V96128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL
Manufacturer: Fisher Diagnostic, A Company of Fisher Scientific LLC, Middletown, VA.
REASON Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.
VOLUME OF PRODUCT IN COMMERCE 11 kits
DISTRIBUTION TX, WA, MT, PA, KY and Korea

PRODUCT SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT.
CODE Box Lot Code: M778940; M779110; M785430; M790190; M791960; M793010; M793020; M793530; M799610; M799620; M803570; M803580; M806400; M806410; M806420; M809020; M810990; M823040; M830430. Pouch Lot Code: M761640; M778400; M781250; M783140; M785270; M791720; M797960; M801010; M802700; M804630; M807010; M811660; M831060; M832790
RECALLING FIRM/MANUFACTURER
Recalling Firm: SonoSite, Inc., Bothell, WA
Manufacturer: Contour Plastics, Inc., Baldwin, WI.
REASON 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
VOLUME OF PRODUCT IN COMMERCE 355 boxes/8,520 pouches
DISTRIBUTION Nationwide and Internationally

PRODUCT STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
CODE Lot number 0422671, Exp. March 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ
Manufacturer: Diagnostica Stago, Franconville, France.
REASON The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
VOLUME OF PRODUCT IN COMMERCE 150 units
DISTRIBUTION Nationwide

Vapotherm ISSUES URGENT NATIONWIDE RECALL OF All Vapotherm® 2000i Respiratory Gas Humidification Devices

Vapotherm, Inc., Stevensville, Maryland, is initiating a nationwide recall of all Vapotherm 2000i Respiratory Gas Humidification devices. Some of these devices have been found to contain the Ralstonia species of bacteria. Ralstonia, as with any gram negative organism, may cause infection, sepsis and in most severe cases be life threatening.

Health care practitioners should seek alternative respiratory gas humidification devices. Any health care facilities that have the Vapotherm 2000i device must return all devices to Vapotherm, Inc. Instructions for return are listed on our recall information website at http://www.vtherm.com/recall or by calling Vapotherm, Inc. at 1-866-827-6843. The “Vapotherm 2000i” label is located on the front of the device on the lower right hand corner. If there is a question in identification of the product please contact Vapotherm for assistance.

This device is used in both the home and in health care institutions for warming and humidifying breathing gases, such as oxygen, delivered by nasal cannula.

The Vapotherm 2000i devices were distributed through specialty distributors in the U.S. and internationally. Consumers with questions regarding this recall may contact the company at 1-866-827-6843, or Kevin Thibodeau at 410-604-3977.