DECEMBER 2006

DECEMBER 2006

WEEK ENDING DECEMBER 2

PRODUCT Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100,
CODE Lot # 37618Q100 Expiration Date 12/05/2006
RECALLING FIRM/MANUFACTURER Abbott Diagnostic International, Ltd., Barceloneta PR,
REASON Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
VOLUME OF PRODUCT IN COMMERCE 2,355 boxes
DISTRIBUTION Nationwide, Hawaii, and PR

PRODUCT Modularis URO urological table, Model number 5531012,
CODE Serial numbers 01001 to 01345
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Potential pinch point with the patient table
VOLUME OF PRODUCT IN COMMERCE 59 units
DISTRIBUTION Nationwide

PRODUCT
a) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004
Femoral Component Size 4, 26006 Femoral Component Size 6,
26008 Femoral Component Size 8 and 26010 Femoral Component Size 10,
b) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014
Femoral Component Size 4, 26016 Femoral Component Size 6, 26018
Femoral Component Size 8 and 26020 Femoral Component Size 10,
CODE
a) All lots considered affected Serial Number: None;
b) Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018:
Lot number 0305.13.2816, 26020: Lot number 0305.13.2817
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego,CA.,
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland.
REASON There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
VOLUME OF PRODUCT IN COMMERCE 80 units
DISTRIBUTION CA

PRODUCT Optetrak, B-series cemented finned tibial tray, size 2f/2t. Catalog # 220-04-02,
CODE Serial numbers: 0886395-0886424
RECALLING FIRM/MANUFACTURER Exactech, Inc., GainesvilleFL.,
REASON Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
VOLUME OF PRODUCT IN COMMERCE 30 units
DISTRIBUTION Internationally

PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1,
CODE
Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit;
CXP version 2.1 Upgrade; 629637 Software Kit;
CXP version 2.0 New User; 629636 Software Kit;
CXP version 2.0 Upgrade; 626553 TN;
FC500 WITH UPS; 6605627 TN;
5 CLR, FC500 (IOOV); 6605628 TN;
5 CLR, FC500 (120V); 6605629 TN;
5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea,CA.,
Manufacturer: Applied Cytometry, Sheffield, UK.
REASON Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.
VOLUME OF PRODUCT IN COMMERCE 476 units
DISTRIBUTION Nationwide and Canada

PRODUCT StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502,
CODE Serial numbers: B1562 to B1738
RECALLING FIRM/MANUFACTURER Iris Sample Processing, Westwood, MA, REASON Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
VOLUME OF PRODUCT IN COMMERCE 94 units
DISTRIBUTION Nationwide

PRODUCT Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, (Catalog No. (ER 00130, 00331, 00230, 00431),
CODE Serial numbers: ER103, ER105, ER106, ER107, ER108, ER110, ER111, ER113, ER115, ER117, ER118
RECALLING FIRM/MANUFACTURER Dako Colorado, Inc., Fort Collins, CO, REASON Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700,
CODE Serial numbers: 11637 thru 12321.
RECALLING FIRM/MANUFACTURER
Gambro Renal Products, Inc., Lakewood CO,
Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy.
REASON Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
VOLUME OF PRODUCT IN COMMERCE 783 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane,
CODE Serial numbers: AETK25021 thru AETK25023, AETK25024, AETK25025, AETK25027 thru AETK25030, AETK27001, AETK27002, AETK27004, AETK27006, AETK27007, AETK27010 thru AETK27015, AETK27017, AETK27019, AETK27020, AETK27024, AETK27025, AETK27027, AETK27031 thru AETK27034, AETK27039, AETK27040, AETK28001 thru AETK28003, AETK28005, AETK28006, AETK28008, AETK28010, AETK28011, AETK28013 thru AETK28017, AETK28019, AETK28021, AETK28023 thru AETK28025, AETK28029, AETK28031thru AETK28038, AETK28040 thru AETK28046, AETK28048, AETK28050 thru AETK28052, AETK28056, AETK28057, AETK28059, AETK28063, AETK28065, AETK28067, AETK28070 thru AETK28072, AETK28074 thru AETK28076, AETK29004, AETK29006, AETK29035, AETK29037, AETK29039, AETK29043, AETK29045, AETK29061, AETK29068, AETK29073, AEWK30001
RECALLING FIRM/MANUFACTURER Datex - Ohmeda, Inc., Madison ,WI,
REASON There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
VOLUME OF PRODUCT IN COMMERCE 93 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Access Point Medical Canes, Cane, Off-Set Crook w/Strap-Black,
Product Code CN10051, packaged 20/case,
b) Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome),
Product Code CN11050, packaged 10/case.,
c) Access Point Medical Canes, Quad Cane, Small Base - Gold,
Product Code CN11050B, and Small Base - Chrome,
Product Code CN11050C, both packaged 6/case,
d) Access Point Medical Canes, Quad Cane, Large Base - Gold,
Product Code CN11070B, and Large Base - Chrome,
Product Code CN11070C, both packaged 6/case,
CODE All canes bearing the model number.
RECALLING FIRM/MANUFACTURER Access Point Medical LLC, St. Louis, MO,
REASON The canes were made of unacceptable materials and could break.
VOLUME OF PRODUCT IN COMMERCE 3,188 canes
DISTRIBUTION Nationwide

PRODUCT Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001, CODE All codes
RECALLING FIRM/MANUFACTURER Medtronic Vascular, Santa Rosa, CA
REASON Sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE 502 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02,
CODE Lot 60472442; exp. May 2011
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN
REASON The polyethylene tibial articular surface may not lock into some of the tibial plates.
VOLUME OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION Nationwide

PRODUCT Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10,
CODE Lots: 60457716 and 60492624
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN
REASON The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
VOLUME OF PRODUCT IN COMMERCE 50 devices
DISTRIBUTION Nationwide and Australia

PRODUCT CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405),
CODE 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC,
Manufacturer: AGFC Corp., Mortsel, Belgium.
REASON Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
VOLUME OF PRODUCT IN COMMERCE 178 units
DISTRIBUTION Nationwide

PRODUCT Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330,
CODE Product code 0770, serial numbers: 0002, 0003, 0011, 0012, 0013, 0014, 0015, 0020, 0021, 0022, 0023, 0024, 0035, 0036, 0037, 0038, 0081, 0082, 0083, 0084, 0085, 0124, 0125, 0126, 0147, 0148, 0149, 0156, 0157, 0158, 0159, 0160; Product code 0771, serial numbers: 0001, 0003, 0004, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0026, 0027, 0028, 0029, 0030, 0034, 0035, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0065, 0066, 0067, 0068, 0069, 0125, 0126, 0127, 0128, 0129, 0155, 0156, 0157, 0159, 0160, 0161, 0162, 0163, 0167, 0168, 0169, 0170, 0234, 0235, 0236, 0241, 0242, 0243, 0244, 0245
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ,
Manufacturer: Konica Medical and Graphic Cor, Shinjuku-Ku, Tokyo, Japan.
REASON The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
VOLUME OF PRODUCT IN COMMERCE 91
DISTRIBUTION Nationwide

PRODUCT Protex Continous Epidural anesthesia tray, Ref 4948-17,
CODE Lot number: 1063342
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Keene, NH, REASON Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch.
VOLUME OF PRODUCT IN COMMERCE 540 units
DISTRIBUTION Nationwide and Panama

WEEK ENDING DECEMBER 9

PRODUCT
a) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104;
b) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107,
c) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1110,
CODE
a) Lot #6000 (Serial numbers: 1480 thru 1489);
Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); &
Lot #6155 (Serial numbers: 1540 thru 1559);
b) Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211
and 5213 thru 5229);
Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169,
5172, 5181, 5152, and 5185 thru 5187); &
Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204,
5206, 5253 and 5255):
c) Lot #5868 (Serial numbers: 7558 thru 7565);
Lot #5890 (Serial numbers: 5230 thru 5243 and 7548) &
Lot #5923 (Serial numbers: 7533, 7536, 7539, 7543 thru 7545, 7548 and 7549)
RECALLING FIRM/MANUFACTURER Lone Star Medical Products, Inc, StaffordTX.,
REASON Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.
VOLUME OF PRODUCT IN COMMERCE 126 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System),
CODE Any serial numbers up to 02160
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nihon Kohden America Inc, Foothill Ranch,CA,
Manufacturer: Nihon Kohden Corp., Shinjuku-ku, Tokyo, Japan.
REASON When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.
VOLUME OF PRODUCT IN COMMERCE 59 units
DISTRIBUTION Nationwide

PRODUCT AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model #DS300,
CODE All Model #DS300 steppers
RECALLING FIRM/MANUFACTURER Computerized Medical Systems, Inc., Saint Louis, MO,
REASON The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
VOLUME OF PRODUCT IN COMMERCE 62 steppers
DISTRIBUTION Nationwide and Internationally

PRODUCT NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-00,
CODE Lot Number: 024448, Exp. Date: March 14, 2008
RECALLING FIRM/MANUFACTURER Inverness Medical Professional Diagnostics, Scarborough, ME,
REASON Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S.pneumonia test pouches.
VOLUME OF PRODUCT IN COMMERCE 533 kits x 22 tests (11,726 tests)
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Roche Modular Drive (rchmdlri), analytical laboratory data interface,
b) Roche Cobas driver (rchcob6i), analytical laboratory data interface,
CODE
a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024;
b) Software version: v8.00.0001 and v7.00.0001
RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South Burlington,VT.,
REASON Software of modular driver may incorrectly report patient results as Quality Control Results.
VOLUME OF PRODUCT IN COMMERCE 56 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Magnetom Trio magnetic resonance imaging, Model number 7387074,
b) Magnetom Trio TIM, magnetic resonance imaging, Model number 10018221,
Model number 10018222,
CODE
a) Serial numbers 20596, 20602, 20613, 20601, 20567, 20557, 20507,
20554, 20559, 20523, 20577, and 20565;
b) Serial numbers 35114, 35115, and 35177;
Serial numbers 35025, 35006, 35022, 35008, 35014, and 35019
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Possible excessive RF exposure/may burn.
VOLUME OF PRODUCT IN COMMERCE 21 units
DISTRIBUTION Nationwide

PRODUCT CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 (packaged 12 strips per box),
CODE All lots.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, .
REASON Erroneous Test Results: Monitor may display "error" message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
VOLUME OF PRODUCT IN COMMERCE Approx. 57,000,000 test strips
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122,
Friadent GmbH. (dental implant),
b) XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123,
Friadent GmbH. (dental implant),
c) XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125,
Friadent GmbH. (dental implant),
CODE
a) Model # 26-0122;
b) Model # 26-0123;
c) Model # 26-0125
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dentsply Friadent Ceramed, Lakewood, CO.,
Manufacturer: Dentsply Friadent GmbH, Mannheim, Germany.
REASON Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
VOLUME OF PRODUCT IN COMMERCE 5,050 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Laborie Transducer Cartridge with Luer Lock Reference: DIS130
CODE Lot Numbers: 36G20M41 and 36H03M005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Laborie Medical Technologies, Williston,VT,
Manufacturer: Smiths Medical, DublinOH.
REASON Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
VOLUME OF PRODUCT IN COMMERCE 2,625 units
DISTRIBUTION Nationwide and Internationally

WEEK ENDING DECEMBER 16

PRODUCT VerifyNow P2Y12 Assay Device Kit, Part Number 85054
CODE Lot Numbers: WK0002A, WK0003A, WK0003B, WK0004A, WK0005A, WK0006A, WK0006AR, WK0006B, WK0006BR, WK0007A, WK0008A, WK0009A, WK0010A, WK0010B, WK0010C, WK0011A, WK0012A, & WK0013A
RECALLING FIRM/MANUFACTURER Accumetrics, Inc., San Diego, CA
REASON The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
VOLUME OF PRODUCT IN COMMERCE 333 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT BioMerieux BacT/Alert SN Anaerobic Culture Bottle-REF 259790, CODE Lot number: 1013177
RECALLING FIRM/MANUFACTURER BioMerieux, Inc., Durham, NC,
REASON Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
VOLUME OF PRODUCT IN COMMERCE 34,400 bottles
DISTRIBUTION Nationwide

PRODUCT Neoprene Pecan Shaped Breathing Bag. Bag with 15 mm neck insert, size 1 liter, a rebreathing bag. Made in UK, Catalog Number (REF) 21176AP,
CODE Lot number: 070318-1
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Teleflex Medical, Bannockburn, IL,
Rusch Manufacturing (U.K.), Teleflex Medical, Armagh, N. Ireland.
REASON Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter. The rebreathing bag is actually a ½ liter bag.
VOLUME OF PRODUCT IN COMMERCE 50 bags
DISTRIBUTION Nationwide

PRODUCT Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model Number: 99120-01
CODE Lot numbers: 3098, 3099, 3100
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA. REASON Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
VOLUME OF PRODUCT IN COMMERCE 4,708 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D,
CODE Lot Numbers: 20071127, 20071128
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., West Sacramento, CA.,
REASON Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
VOLUME OF PRODUCT IN COMMERCE 828 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Sling Rope/Connector Assembly Kits for the Sara and Sara Nova
standing and raising aids; the kit is comprised of 2 x 200 cm ropes,
2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and
2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172;
Model KS1006,
b) Sling Rope/Connector Assembly Kits for the Sara Power standing
and raising aids; the kit is comprised of 2 x 230 cm ropes, 2 knobs,
2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers;
Model KS1019,
CODE All kits shipped between July 2006 through September 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer: Medibo, N.V., Hanmont, Achel, Belgium.
REASON The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
VOLUME OF PRODUCT IN COMMERCE 25 rope lots
DISTRIBUTION Nationwide

PRODUCT VITROS® Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS® Chemistry Systems typically used in hospital laboratories. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08,
CODE All lots
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester NY,
REASON The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS® LIPA slides if they have been stored on the VITROS® Chemistry Systems for more than 2 days.
VOLUME OF PRODUCT IN COMMERCE 10.777 units
DISTRIBUTION Nationwide and Internationally

WEEK ENDING DECEMBER 23

PRODUCT One Touch Ultra test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips,
CODE Lot No. 2691191, exp 2008-02
RECALLING FIRM/MANUFACTURER Discount Diabetic Supply, Oxford MS, REASON Counterfeit-Blood glucose test strips were reported to be counterfeit.
VOLUME OF PRODUCT IN COMMERCE 240 units
DISTRIBUTION Nationwide

PRODUCT OneTouch®/Basic®/Profile® Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese),
CODE Lots 2606340, 2619932, 272894A; Part # 020-848.
RECALLING FIRM/MANUFACTURER Medishop, Inc., Brooklyn, NY
REASON Counterfeit-The product is reported to be counterfeit
VOLUME OF PRODUCT IN COMMERCE 7,727 boxes (50 strips per box)
DISTRIBUTION Nationwide and Internationally

PRODUCT AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
CODE Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana CA,
Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco, PR.
REASON The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
VOLUME OF PRODUCT IN COMMERCE 10 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280,
b) Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290,
c) Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300,
d) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400,
e) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401,
f) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405,
g) Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406,
h) Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409,
i) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.,
j) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268,
CODE
a) Serial numbers 5305, 5377 and 5379;
b) Serial numbers 5304, 5306 through 5329, 5335, 5336, 5338, 5345, 5348, 5349, 5351, 5352, 5353, 5354, 5355, 5357 through 5361, 5363 through 5367, 5371 through 5376, 5380, 5385 through 5388, 5390 through 5395, 5399, 5401 through 5408, 5410, 5414, 5417, 5422, 5428, 5429, 5431, 5432, 5435, 5438, 5440, 5443, 5447, 5448, 5449, 5450, 5452, 5453 and 5463;
c) Serial numbers 5331, 5332, 5333, 5334, 5337, 5339, 5340, 5341, 5342, 5343, 5344, 5346, 5347, 5350, 5356, 5362, 5368, 5369, 5370, 5378, 5383, 5384, 5389, 5396, 5397, 5398, 5400, 5409, 5411, 5412, 5413, 5415, 5416, 5418, 5419, 5420, 5421, 5423, 5424, 5425, 5430, 5433, 5434, 5436, 5437, 5439, 5441, 5442, 5444, 5445, 5446, 5451, 5454, 5455, 5456, 5457, 5458, 5459, 5460, 5461 and 5462;
d) Serial numbers 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140 1141, 1143 through 1194 and 1196 through 1245;
e) Serial numbers 1396 through 1501, 1570 through 1647, 1650 through 1679, 1681 through 1778, 1781 through 1821, 1824 through 1837 and 1839 through 1986;
f) Serial numbers 1126 through 1305;
g) Serial numbers 1081 through 1177 and 1179 through 1213;
h) Serial numbers 1020, 1021, 1022, 1023, 1024, 1025 and 1026;
i) Serial numbers 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061
and 1602 through 1621;
j) Serial numbers 1997 through 2005, 2011 through 2068, 2070 through 2077, 2079 through 2137, 2141 through 2154, 2156 through 2241, 2243 through 2257, 2259, 2260, 2262, 2263, 2265 through 2274, 2276 through 2278, 2280, 2282 through 2310, 2312 through 2350, 2353 through 2365, 2367 through 2460,
2462 through 2475, 2477 through 2485, 2488 through 2523, 2526 through 2555, 2558 through 2583, 2585 through 2600, 2602, 2606 through 2621, 2624 through 2628, 2630 through 2636, 2638, 2639, 2641 through 1645, 2647, 2650, 2652 through 2657 and 2661 through 2668
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
REASON The hand crank handle may separate and detach from the unit during use.
VOLUME OF PRODUCT IN COMMERCE 1,836 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Level 1® Normothermic I.V. Fluid Administration Set REF D-60HL,
b) Level 1® Normothermic I.V. Fluid Administration Set REF DI-60HL
(Foreign Distribution Only),
CODE
a) Lot numbers: 1009446, 1035977, 1043174, 1046075, 1048466, 1060983;
b) Lot number: 725769, 1011870, 1019492, 1011871, 1027190, 1028662, 1037117, 1037809, 1049619, 1058925, 1060998, 1064376, 1067796, 1067797, 1074088, 1074089
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Rockland, MA,
REASON IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
VOLUME OF PRODUCT IN COMMERCE 13,640 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD,
CODE UPC (01)30382903649021 Catalog # 364902 Lot # 6138499 Exp. 4/09 Catalog # 364902 Lot # 6144043 Exp. 4/09 Catalog # 364902 Lot # 6144082 Exp. 4/09 Catalog # 364902 Lot # 6144090 Exp. 4/09 Catalog # 364902 Lot # 6144128 Exp. 4/09 Catalog # 364902 Lot # 6150373 Exp. 4/09 Catalog # 364902 Lot # 6150365 Exp. 5/09 Catalog # 364902 Lot # 6153085 Exp. 5/09 Catalog # 364902 Lot # 6154356 Exp. 5/09 Catalog # 364902 Lot # 6154358 Exp. 5/09 Catalog # 364902 Lot # 6173027 Exp. 5/09 Catalog # 364902 Lot # 6173028 Exp. 5/09 Catalog # 364902 Lot # 6178307 Exp. 5/09 Catalog # 364902 Lot # 6178357 Exp. 5/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Vacutainer Micrope, San Lorenzo, PR.
REASON Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
VOLUME OF PRODUCT IN COMMERCE 1,744,400 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Calstrux™ (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc,
CODE Lot Numbers: 5cc: TUAN003, TUAN007, TUBN012, TUBN013, TUCN018, TUEN023, TUEN024. 10cc: TUAN002, TUAN004, TUAN006, TUBN01. 15cc: TU06026, TUAN001, TUAN005, TUAN008, TUBN009, TUBN015, TUBN016, TUCN019, TUCN020, TUDN021, TUDN022, TUEN025
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Biotech, Hopkinton, MA,
Manufacturer: Howmedica International S de RL, Limerick, Ireland.
REASON Lack of Labeling Precautions. Calstrux™ should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.
VOLUME OF PRODUCT IN COMMERCE 3,304 units
DISTRIBUTION Nationwide and Internationally

PRODUCT AMO PhacoFlex Il Model SI40NB Intraocular Lenses,
CODE Serial Numbers: 1114110408, 1119570408, 1142040205, 1143100207, 1147320306, 1147330306, 1157290307, 1159120306, 1200580409, 1200700409, 1215800307, 1245260307, 1251300402, 1269240205, 1312400308, 1320420307, 1322770202, 1339940208, 1346040309, 1376660402, 1403090305, 1519560303, 1519570303, 1537150408, 1544970308, 1545920407, 1552190306, 1644880406, 1649280409, 1701830307, 1718970304, 1736210308, 1771500312, 1793030407, 1794700312, 1812750311, 1850350301, 1852450310, 1868930404, 1869430308, 1891830306 & 1897480311.
All lenses are clearly identified with a 10 digit serial number. The format of the serial number is described below: Example of serial number format for lens: 1230010212. The first digit denotes the particular manufacturing plant within the AMO facility at Anasco, Puerto Rico, where the product was manufactured. The first digit codes are: - 1 or 2: Silicone Plant - 3: Silicone Rework Plant - 4 or 5: Acrylic Plant - 6: Acrylic Rework Plant Digits two through six denote the sequence of numbers assigned to the lenses. The seven and eighth digit denote the year of manufacture. The ninth and tenth digit denote the month of manufacture. In the serial number example above, the serial number represents the 23001 lens produced in the Silicone plant.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA
Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco PR.
REASON These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
VOLUME OF PRODUCT IN COMMERCE 55 units
DISTRIBUTION Nationwide

PRODUCT Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; CODE Lots: 06JC0016 and 06JC0017, Exp. 08-08
RECALLING FIRM/MANUFACTURER Medline Industries, Inc, Mundelein, IL, REASON The product, labeled as sterile, had not gone through the sterilization process at the time of shipment
VOLUME OF PRODUCT IN COMMERCE 47 cases
DISTRIBUTION MN, IL, WI, and IN

PRODUCT Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials,
CODE Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506b, QP3000506C, QP3000606, QP3000706
RECALLING FIRM/MANUFACTURER Biogenex Laboratories, San Ramon, CA,
REASON Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as ''1 x 100 mL Alk Phos Label'' which should read ''1 x 100 mL HRP Label''. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.
VOLUME OF PRODUCT IN COMMERCE 158 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Custom 5.5 mm Bivona® Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S,
CODE Lot CL47189.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN, REASON Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION NY

Boston Scientific Announces Nationwide Recall of 51 Mach 1 Guide Catheters

Boston Scientific Corporation (NYSE: BSX) is recalling certain lots of the Mach 1® Guide Catheter in the United States. The affected lots of Guide Catheters are 687532, 687586, 687593, 687596, 687654, 687753, 687754, 688035, 687877, 687878, 687879 and 688002. The total number of devices involved in this recall is estimated at 51.

The Guide Catheter is a tube that is thread through the body and allows delivery of medical devices to the heart to treat coronary artery disease. The Company is initiating this recall because it has determined, through internal inspections, that in some product units, excess strands of resin may exist in the inner lumen near the hub of the guide catheter. If the excess resin is present in the catheter and detaches during a procedure, there is the potential for embolization, in which strands of resin could obstruct a blood vessel. An obstruction of a small blood vessel by an embolism may not cause tissue damage; however, an obstruction of a major blood vessel or multiple small blood vessels could result in serious complications such as stroke, heart attack or kidney problems. To date, no product complaints have been reported to Boston Scientific related to this issue, and there have been no reported injuries.

The products affected by this recall were distributed only to hospitals in the United States. Boston Scientific is notifying affected hospitals through detailed recall notification letters requesting that use of the product affected by this recall should cease immediately. Instructions on how to return product are included in the notification letters. Replacement product will be available for all affected product.

To arrange for return of affected product, please contact Boston Scientific at 1-800-811-3211.

WEEK ENDING DECEMBER 30

PRODUCT
a) One Touch Basic/Profile Blood Glucose test strips,
b) One Touch Ultra Blood Glucose Test Strips,
CODE
a) Lot Numbers: 2619932, 2606340;
b) Lot Number: 2691191
RECALLING FIRM/MANUFACTURER Medical Plastics Devices Inc, Point Claire, Quebec, Canada,
REASON Counterfeit Glucose Test Strips.
VOLUME OF PRODUCT IN COMMERCE 3353 boxes
DISTRIBUTION Nationwide

PRODUCT OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters,
CODE OneTouch Ultra, Lot 2691191 and 2691261. OneTouch, Lot 2615211
RECALLING FIRM/MANUFACTURER Milwaukee Notions, Inc., Union Grove, WI,
REASON Counterfeit
VOLUME OF PRODUCT IN COMMERCE 1,512 OneTouch Ultra and 183 OneTouch basic
DISTRIBUTION Nationwide

PRODUCT
Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows:

a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. '9-DEL-5F-180/60' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).]

b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise,
Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. '9-EXCH-6F180/80' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise.
AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. '9-TVSP-7F-180/80' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use.

c) The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath,
CODE
a) Order no. 9-DEL-5F-180/60, Lot Numbers: M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15, M04L02-04, M04M28-10, M05C15-31, M05C25-27, M05D29-51, M05G20-44, M05G28-19, M05H30-45, M05J23-32. Order no. 9-DEL-6F-45/60, Lot Numbers: M03L11-45, M03J23-04, M04B09-16, M04E27-19, M04L22-12, M05A03-10, M05B04-20, M05B08-04, M05C08-23, M05C09-05, M05E24-48, M05H01-51, M05J12-16, M06C20-25, M06D03-02, M06D19-71, M06E22-46. Order no. 9-DEL-6F-180/80, Lot Numbers: M03K16-22, M03K28-33, M03L11-47, M03M02-09, M03M03-09, M03M12-18, M04A19-31, M04B03-10, M04C01-17, M04C23-12, M04D06-10, M04D13-16, M04E24-16, M04F23-21, M04F28-40, M04G01-22, M04G27-27, M04H03-17, M04H12-11, M04H24-23, M04L08-02, M04M16-21, M04M30-04, M05A03-09, M05A05-27, M05A12-07, M05A17-07, M05A18-04, M05A20-09, M05A27-27, M05A31-06, M05B02-26, M05B21-13, M05B23-09, M05C08-04, M05C25-02, M05D07-08, M05D13-09, M05D14-13, M05G07-20, M05G11-03, M05G12-06, M05G15-24, M05G15-31, M05G27-41, M05H08-19, M05H04-10, M05H05-29, M05H09-09, M05K14-06, M05K20-10, M05K28-02, M05M28-23, M06A13-17, M06D19-53, M06D19-57, M06D19-55, M06D19-59, M06E16-68, M06E22-65, M06E22-67, M06F07-90, M06F13-86. Order no. 9-DEL-7F-45/60, Lot Numbers: . Order no. , Lot Numbers: M03L12-09, M04C23-09, M04E24-17, M04G01-24, M04M10-18, M05B04-18, M05B07-06, M05B16-02, M05D08-09, M05F13-11, M05G15-16, M05G19-24, M05J08-03. Order no. 9-DEL-7F-45/80, Lot Numbers: M03J19-07, M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14, M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23, M04H03-23, M04J17-07, M04K07-02, M04K28-06, M04L30-04, M05A11-12, M05A11-10, M05A12-05, M05B04-09, M05B16-04, M05B16-23, M05B23-07, M05C10-07, M05C14-07, M05C15-29, M05D04-15, M05E03-02, M05E12-16, M05E12-03, M05E16-21, M05E17-45, M05F01-02, M05F30-25, M05G07-02, M05G21-06, M05G29-23, M05H01-11, M05H17-09, M05J16-13, M05J16-68, M05J28-08, M05K04-04, M05M05-11, M06A13-19, M06C20-23, M06C28-42, M06D04-77, M06D12-20, M06E16-80, M06F01-43, M06F07-88, M06F13-76, M06G25-96. Order no. 9-DEL-7F-180/80, Lot Numbers: M03K24-14, M03L12-10, M03M12-19, M03G15-34, M04B03-08, M04B09-17, M04C01-18, M04D01-05, M04D06-11, M04D20-07, M04E04-05, M04F08-21, M04H03-18, M04H24-25, M04K22-13, M04L30-12, M04M13-05, M05A18-26, M05A20-11, M05B08-06, M05B14-22, M05B18-10, M05B18-12, M05C16-33, M05C16-18, M05D05-39, M05E11-30, M05E18-04, M05E26-23, M05G08-07, M05G15-29, M05G26-16, M05H02-22, M05H03-11, M05J13-14, M05J19-66, M05J23-07, M05J26-19, M05K19-04, M05L30-22, M05M22-20, M06D19-67, M05D19-69, M06E16-76, M06E22-71, M06E22-69. Order no. 9-DEL-8F-45/60, Lot Numbers: M03K14-07, M03L18-50, M03M03-11, M04C23-10, M04E24-18, M04G01-20, M04L30-02, M04M15-20, M05B07-08, M05B14-04, M05B15-07, M05B24-14, M05B25-06, M05H19-13. Order no. 9-DEL-8F-45/80, Lot Numbers: M03J19-08, M03J25-27, M03K09-23, M03K28-36, M03L11-46, M03M03-12, M03M29-07, M04A19-28, M04A28-16, M04B03-13, M04B09-19, M04B17-33, M04B24-08, M04C23-11, M04D06-13, M04D26-06, M04D26-10, M04F08-22, M04F27-47, M04H24-22, M04J07-09, M04J10-22, M04J17-08, M04J17-09, M04K06-02, M04K11-08, M04K15-10, M04K25-25, M04L02-02, M04L08-12, M04L29-18, M04M01-02, M04M10-08, M04M20-16, M04M22-02, M04M30-05, M05A11-08, M05A18-28, M05A21-20, M05A21-24, M05A24-34, M05A27-13, M05A28-13, M05A31-08, M05B17-04, M05B17-06, M05C21-24, M05C24-04, M05C25-18, M05C30-24, M05C31-28, M05D06-07, M05D12-03, M05D14-09, M05D20-06, M05D25-19, M05D27-20, M05D28-13, M05E24-17, M05E25-21, M05E27-46, M05F06-46, M05F21-43, M05F21-41, M05G20-10, M05G27-39, M05H12-16, M05H17-13, M05H24-19, M05J09-10, M05J09-12, M05K11-03, M05K18-10, M05K20-08, M05K21-05, M05L17-19, M05L21-04, M05L28-04, M05L30-20, M06A09-15, M06A12-10, M06A12-12, M06A20-25, M06A20-27, M06A24-18, M06A20-29, M06C17-36, M06C17-38, M06D04-73, M06D11-05, M06D12-12, M06D12-14, M06D12-16, M06D12-18, M06E22-49, M06E22-51, M06F01-47, M06F07-82, M06F07-84, M06F07-86, M06F13-72, M06F13-74, M06F22-19, M06F29-12, M06G24-46. Order no. 9-DEL-8F-180/80, Lot Numbers: M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24, M04H03-20, M04K26-18, M04L04-17. M05B11-08, M05C01-06, M05C01-08, M05C11-02, M05E02-21, M05F28-12, M05J01-38, M05J22-28, M05K18-04. Order no. 9-DEL-9F-45/80, Lot Numbers: M03K14-08, M03K24-15, M03K28-37, M03M02-12, M03M03-08, M03M29-03, M03M29-06, M03M30-13, M04A19-29, M04A28-18, M04B03-12, M04B17-38, M04C08-13, M04C15-04, M04C15-06, M04D06-09, M04D13-17, M04D20-08, M04D26-07, M04D26-09, M04E24-19, M04E27-24, M04F21-43, M04F23-23, M04G27-25, M04H12-12, M04H24-20, M04J22-13, M04K08-02, M04L05-08, M04L19-11, M04L29-02, M04L29-17, M04L29-23, M04L30-10, M04M14-02, M04M14-04, M04M14-21, M04M16-23, M04N22-23, M05A05-25, M05A03-12, M05A11-06, M05A13-19, M05A18-24, M05A19-04, M05A24-09, M05A24-32, M05A24-36, M05A25-19, M05A28-11, M05B01-05, M05B02-24, M05B04-22, M05B10-05, M05B11-06, M05B22-03, M05B23-05, M05B24-20, M05C10-25, M05C15-27, M05C24-02, M05D04-13, M05D06-05, M05D07-04, M05D08-11, M05D12-20, M05D26-26, M05E11-14, M05E11-16, M05E13-09, M05E31-04, M05E31-10, M05E31-12, M05F06-44, M05F03-12, M05F09-06, M05F10-07, M05F14-26, M05F16-17, M05F27-06, M05F29-06, M05G06-07, M05G18-30, M05G19-15, M05G27-07, M05G27-43, M05H01-09, M05H12-14, M05H18-34, M05H19-08, M0530-36, M05J07-10, M05J08-05, M05J16-57, M05L01-02, M05L18-02, M05L30-06, M05M02-21, M05M06-13, M05M08-16, M05M22-12, M05M22-16, M06A09-12, M06A16-23, M06C15-52, M06C20-27, M06C24-22, M06D04-69, M06D04-71, M06D19-61, M06D19-63, M06D21-03, M06D21-05, M06D21-07, M06E22-53, M06E22-55, M06F13-78, M06F29-10, M06G25-93. Order no. 9-DEL-9F-180/80, Lot Numbers: M03K28-34, M03L18-51, M04L22-14, M05C28-12, M05D07-10, M05E03-13, M05F22-09, M05J26-21. Order no. 9-DEL-10F-45/80, Lot Numbers: M03J25-26, M03K01-02, M03K09-22, M03K14-05, M03K16-16, M03K16-17, M03K24-09, M03L18-56, M03M30-11, M03M30-14, M03M30-15, M04A19-30, M04B03-11, M04B17-34, M04B24-09, M04C30-08, M04F08-20, M04F23-20, M04F28-46, M04G01-19, M04G01-21, M04H23-20, M04H23-21, M04J07-04, M04L29-19, M04L29-20, M04M22-25, M04M17-19, M04M29-09, M04M29-10, M05A03-11, M05A10-07, M05A10-09, M05A14-08, M05B07-24, M05B07-25, M05B07-26, M05B18-06, M05B21-04, M05B24-08, M05C03-08, M05C07-06, M05C10-05, M05C10-27, M05C15-25, M05C23-07, M05C29-13, M05D29-05, M05E04-17, M05E05-24, M05E09-19, M05E09-21, M05E16-19, M05E17-43, M05E24-13, M05E27-38, M05E26-33, M05F09-08, M05F28-08, M05F28-10, M05H03-37, M05H22-06, M05H25-15, M05H25-13, M05J01-13, M05J22-23, M05K10-07, M05K13-04, M05K19-02, M05K21-03, M05L18-04, M05L29-12, M05M02-23, M05M01-05, M05M22-18, M06A13-15, M06C15-55, M06C24-20, M06D04-65, M06D04-67, M06E08-10, M06E08-12, M06F07-80, M06F13-82, M06G25-94. Order no. 9-DEL-12F-45/80, Lot Numbers: M03J25-28, M03K16-21, M03K24-13, M03L18-55, M03M03-13, M03M30-12, M03M30-16, M04A28-19, M04C09-03, M04C09-04, M04C15-05, M04D01-04, M04D06-08, M04D26-08, M04F21-42, M04F23-22, M04G27-26, M04H03-22, M04H24-21, M04J30-02, M04K05-02, M04K25-23, M04L04-09, M04M10-05, M04M23-02, M05A13-03, M05A14-11, M05A19-06, M05B04-24, M05B21-28, M05C03-04, M05C02-06, M05C07-08, M05C08-02, M05C21-25, M05D07-06, M05D15-28, M05D19-02, M05D18-45, M05D25-04, M05D28-23, M05D29-19, M05E02-08, M05E10-29, M05E13-26, M05E19-07, M05E20-17, M05E24-15, M05F07-12, M05F15-35, M05F15-43, M05F20-05, M05F21-54, M05G13-16, M05G25-15, M05G27-09, M05H05-27, M05H26-08, M05H29-16, M05J09-27, M05J12-09, M05J12-07, M05K06-10, M05K07-25, M05K31-28, M06C15-57, M06D04-75, M06D12-10, M06E16-78, M06F01-45, M06F13-84. the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, Lot numbers: M05K24-25, M05L03-06, M06C03-17, M06C27-05, M06E22-57. Order no. 9-ITV07F45/60, Lot numbers: M05K24-27, M05L04-13, M06B10-21, M06E01-40, M06F13-96. Order no. 9-ITV07F45/80, Lot numbers: M05K24-04, M05L10-07, M05L14-13, M05L15-34, M06B01-31, M06C02-14, M06F01-33, M06F07-68, M06F07-70. Order no. 9-ITV08F45/60, Lot numbers: M05K24-29, M05L03-08, M06B10-25. Order no. 9-ITV08F45/80, Lot numbers: M05K24-31, M05L11-15, M05M06-17, M05M07-10, M05M12-16, M06A05-25, M06B01-33, M06B10-27, M06B10-23, M06E03-10, M06E03-08, M06E16-84, M06F01-41, M06F13-90, M06G06-18, M06G25-79. Order no. 9-ITV09F45/80, Lot numbers: M05K24-33, M05L10-09, M05M12-18, M05M12-20, M06A12-19, M06B01-37, M06B10-29, M06C03-14, M06C10-18, M06C10-20, M06C13-38, M06C13-40, M06D19-73, M06D26-26, M06D26-28, M06D26-30, M06F01-39, M06F07-76, M06F07-72, M06F13-98, M06F14-03, M06F22-17, M06F14-01, M06G24-28, M06F22-15. Order no. 9-ITV10F45/80, Lot numbers: M05K24-06, M05L02-12, M05M07-12, M05M12-22. M06B01-39, M06C02-16, M06C10-22, M06C10-24, M06C13-42, M06C13-44, M06D12-08, M06D12-06, M06F13-92, M06G06-24, M06G06-22. Order no. 9-ITV12F45/80, Lot numbers: M05K24-35, M05L14-09, M05M05-15, M05M12-24, M06B01-41, M06C02-18, M06C20-39, M06C10-28, M06C10-26, M06D12-01, M06E03-04, M06E09-59, M06G25-89. Order no. 9-ITV05F180/60, Lot numbers: M05K24-02, M05L02-15, M06C27-07. Order no. 9-ITV06F180/60, Lot numbers: Order no. 9-ITV06F180/80, Lot numbers: M05K24-08, M05L03-10, M05L04-15, M05L17-23, M05L28-03, M06C20-29, M06C20-31, M06C27-08, M06C20-33, M06E01-05, M06G06-26. Order no. 9-ITV07F180/80, Lot numbers: M05K24-10, M05L08-06, M05L15-28, M05L17-25, M06B17-34, M06B21-43, M06B21-45, M06B21-47, M06G24-24. Order no. 9-ITV08F180/80, Lot numbers: M05K24-23, M05L11-17, M06B17-28, M06D19-65, M06E08-05. Order no. 9-ITV09F180/80, Lot numbers: M05K24-21, M05L07-06, M06B17-32;
b) Order no. 9-EXCH6F-180/80, Lot Numbers: M05F10-13, M06F22-25. Order no. 9-EXCH8F-180/80, Lot numbers: M04D01-06, M04E27-21, M05C23-13. Order no. 9EXCH9F-45/80, Lot Numbers: M03L18-54, M05A12-09, M05D19-10, M05D18-47, M05E23-37, M05G15-06, M05H18-36. Order no. 9-EXCH12F-45/80, Lot Numbers: M05A13-23, M05B04-11, M05B14-08, M05C30-11, M05E02-19, M05H08-20. The following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, Lot numbers: M06A05-31, M05L15-24. Order no. 9-EITV12F45/80, Lot numbers: M06A05-33, M05L15-26. Order no. 9-EITV06F180/80, Lot numbers: M06D19-51. Order no. 9-EITV08F180/80, Lot numbers: M05L15-32, M06G26-02;
c) Order no. 9-TVSP7F-180/80, Lot Numbers: M03K16-18, M03K24-10, M03K28-30, M03L06-36, M03L12-04, M03M02-10, M04B17-36, M04E18-12, M04E27-16, M04H31-16, M04L15-16, M05C09-09, M05C25-06, M05D20-17, M05E05-20, M05E23-39. Order no. 9-TVSP8F-180/80, Lot Numbers: M03J17-08, M03K16-19, M03K24-11, M03K28-31, M03L06-37, M03L12-05, M03M02-11, M03M30-10, M04B17-37, M04E27-17, M04L08-10, M05A13-05, M05C25-08, M05E05-07, M05F17-10. Order no. 9-TVSP9F-180/80, Lot Numbers: M03J17-09, M03K16-20, M03K24-12, M03K28-32, M03L06-38, M03L12-06, M04E27-18, M04H03-21, M04L15-18, M05D11-12, and M05D20-19.
RECALLING FIRM/MANUFACTURER:
AGA Medical Corporation, Golden Valley MN, by facsimile or e-mail dated September 29, 2006. Firm initiated recall is ongoing
REASON AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
VOLUME OF PRODUCT IN COMMERCE 107,484 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Invasive Blood Pressure Interface Cables:

a) Medrad 9500 Multigas monitor for MRI,
Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira
IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use
with Braun IBP Transducers. The product is an accessory to patient physiological
monitor,
b) Veris Invasive Blood Pressure Interface Cables-Part # 3010478.
The product is an accessory to patient physiological monitor,
CODE a) and b) Catalog number 3006314, 3010478, and 3008772
RECALLING FIRM/MANUFACTURER Medrad Inc, Indianola, PA.
REASON Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
VOLUME OF PRODUCT IN COMMERCE 80 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D),
CODE
Model H210, Serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525;
Model H215, Serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425;
Model H217, Serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350;
Model H219, Serial numbers: 203320, 203344, 203355, 203377, 203382;
Model H230, Serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155;
Model H239, Serial numbers: 650451, 650453, 650454
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN,
Manufacturer: Guidant-Ireland, Clomel, County Tipperary, Ireland.
REASON Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
VOLUME OF PRODUCT IN COMMERCE 57 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter.
Latex Free A Port Ref Product No. AP-01007;
b) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port,
c) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535, d) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530,

e) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port , 12 Fr. Introducer Kit. Ref Product Code: AP-06528,
f) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port, 10 Fr. Introducer Kit. Ref Product No. AP-06520,
g) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046,
h) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042,
i) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040,
j) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036,
k) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022,
l) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020,
m) Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter.
Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018,
n) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.Latex-Free Low Profile Port. 6 Fr. Introducer Kit. Ref. Product No. AP-06016,
o) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015,
p) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014,
q) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber
Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013,
r) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber
Catheter. Latex-Free A Port. Ref Product No. AP-01510,
CODE
a) Lot Numbers: MF2041118, MF2112625, MF3013201, MF3105944, MF4031465;
b) Lot Numbers: 11284, MF3085483, MF4031500, MF4063259;
c) Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636,
MF6014780, MF6025930, MF6079639, MR2070141;
d) Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934,
MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656,
MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148;
e) Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038,
MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293,
MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936,
MF6079334;
f) Lot Number: MF1033516, MF2071649, MF2081937, MF2082002, MF2092208,
MF2092278, MF2102373, MF2102462, MF2112595, MF2112688, MF2122960,
MF3013060, MF3013065, MF3013198, MF3013279, MF3013308, MF3023367,
MF3023427, MF3033567, MF3033642, MF3033732, MF3043847, MF3043910,
MF3044134, MF3054228, MF3054338, MF3054447, MF3054465, MF3064645,
MF3064763, MF3064833, MF3074927, MF3075118, MF3085281, MF3095491,
MF3095574, MF3095611, MF3105931, MF3106006, MF3116245, MF3126277,
MF3126278, MF3126318, MF3126396, MF3126417, MF3126450, MF4016582,
MF4016635, MF4020551, MF4020553, MF4020806, MF4031020, MF4031582,
MF4041771, MF4041936, MF4052333, MF4063058, MF4073792, MF4083964,
MF4084041, MF4084292, MF4094582, MF4094706, MF4105124, MF4105261,
MF4105486, MF4105803, MF4116118, MF5017414, MF5017549, MF5027701,
MF5028033, MF5028158, MF5038602, MF5050176, MF5059737, MF5060355,
MF5060468, MF5071341, MF5081670, MF5081671, MF5081762, MF5081870,
MF5081902, MF5082122, MF5082249, MF5092841, MF5093006, MF5103341,
MF5103508, MF5113683, MF5113875, MF5114153, MF5124319, MF5124528,
MF6014777, MF6025871, MF6026069, MF6026200, MF6036711, MF6057765,
MF6058113, MF6058190, MF6058298, MF6068660, MF6079304, MF6089737,
MF6089985, MS3110155, MS3110156, MS3110157, MS3110158, MS4031056,
MS4031058, MS4031059, MS4031065;
g) Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934,
MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353,
MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769;
h) Lot Numbers: 11916, MF2092169, MF2092256, MF3013079, MF3013159,
MF3013315, MF3013320, MF3023358, MF3033614, MF3043940, MF3064659,
MF3054234, MF3075086, MF3075140, MF3116147, MF3126395, MF4016579,
MF4031049, MF4031484, MF4063059, MF4063266, MF4105260, MF4105483,
MF4115980, MF4126889, MF4126890, MF5027945, MF5059894, MF5060175,
MF5092679, MF5103210, MF5113791, MF5124527, MF6015496, MF6025735,
MF6026194, MF6057764, MF6080022, MR3110192, MR3110194, MS2100122,
MS4041843, MS4041844, MS4041845;
i) Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424,
MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288,
MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539,
MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056,
MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044,
MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066,
MF6047369, MF6047370, MF6025851, MF6057763;
j) Lot Numbers: MF2081824, MF2092267, MF3013206, MF3023468, MF3033568,
MF3043935, MF3054360, MF3054525, MF3126300, MF4016726, MF4031047,
MF4042099, MF4062964, MF4105288, MF4105802, MF4126773, MF5027944,
MF5038765, MF5070950, MF5124151, MF6014960, MF6036562, MF6047448,
MF6058105, MF6058348, MF6036931, MF6068655;
k) Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612,
MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767,
MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950,
MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146,
MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351,
MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285,
MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407,
MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649,
MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992,
MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368,
MF6057762, MF6058411, MF6068650, MS3110150, MS4041840;
l) Lot Numbers: MF1075363, MF2071759, MF2071795, MF2081849, MF2081900,
MF2122871, MF2122962, MF3013303, MF3023498, MF3033750, MF3054449,
MF3054482, MF3085186, MF3085246, MF3085395, MF3095548, MF3116233,
MF3116244, MF4020723, MF4020901, MF4031014, MF4031015, MF4031466,
MF4052331, MF4062929, MF4063264, MF4084283, MF4094580, MF4094705,
MF4105328, MF4105577, MF4115963, MF4126528, MF4126656, MF4126883,
MF4126884, MF5017406, MF5027697, MF5028032, MF5028154, MF5038599,
MF5050172, MF5059730, MF5059892, MF5060353, MF5060465, MF5070948,
MF5081719, MF5081720, MF5124397, MF5082119, MF5092548, MF5103503,
MF5103681, MF5113874, MF5124524, MF6014999, MF6047362, MF6047363,
MF6047523, MF6057740, MF6057761, MF6068649, MF6068928, MF6079295,
MF6079297;
m) Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309,
MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061,
MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725,
MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052,
MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881,
MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322,
MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502,
MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618,
MF6058293, MF6058347, MF6068925;
n) Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372,
MF4073836, MF4105283, MF6015284, MF6026177;
o) Lot Number: 11953, 12024, 12048, MF2122834, MF2122873, MF3013094,
MF3023399, MF3033565, MF3033661, MF3043929, MF3044026, MF3044155,
MF3054297, MF3054407, MF3064741, MF3074954, MF3085360, MF3106021,
MF4016605, MF4020460, MF4031011, MF4031501, MF4041930, MF4062927,
MF4063051, MF4073944, MF4094579, MF4094883, MF4095027, MF4116113,
MF4126523, MF5017401, MF5049107, MF5049320, MF5059727, MF5060170
,MF5060348, MF5060463, MF5081716, MF5082118, MF5082247, MF5113788,
MF5113989, MF5124143, MF6014773, MF6025691, MF6036470, MF6036928,
MF6047447, MF6057759, MF6058188, MF6068647, MF6079327, MS3110160,
MS4073806;
p) Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186, MF3116232,
MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653,
MF5049105, MF5050037, MF5092675, MF5103680, MF6014995, MF6079156,
MF6089978;
q) Lot Numbers: MF2102345, MF2112624, MF2122835, MF3013200, MF3023408,
MF3023552, MF3033766, MF3054406, MF3074987, MF3075143, MF3095708,
MF3105784, MF3116130, MF3116231, MF4016530, MF4020444, MF4020470,
MF4041797, MF4062926, MF4073773, MF4084282, MF4094881, MF4116112,
MF4126522, MF4126770, MF4126879, MF5017542, MF5028152, MF5038758,
MF5049103, MF5059726, MF5060460, MF5081715, MF5082408, MF5092546,
MF5103679, MF5113983, MF6014772, MF6026163, MF6036927;
r) Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869,
MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233,
MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651,
MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739,
MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605,
MS4041616, MS4041617,MS4041618
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA,
Manufacturer: Arrow International, Inc., Mount Holly, NJ.
REASON Catheter has separated from the infusion port body.
VOLUME OF PRODUCT IN COMMERCE 10,594 devices
DISTRIBUTION Nationwide

PRODUCT OptiVantage DH Power Injection System,
CODE All codes
RECALLING FIRM/MANUFACTURER Mallinckrodt Inc., Cincinnati OH
REASON The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinician, contrast would be injected at a higher or lower flow rate than desired.
VOLUME OF PRODUCT IN COMMERCE 1,348 devices
DISTRIBUTION Nationwide and Internationally

DEVICE RECALL EXTENSION
Originally listed for week ending December 30, 2006

PRODUCT
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, CODE
All cans manufactured prior to 11/18/06 Replacement product will have a new date/lot code on the bottom of the can which will end in R3X.
******* On 2/26/07 the firm expanded the recall to include the replacement product which has a lot code on the bottom of the can that ends in R3X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: KaVo America Corp, Lake Zurich IL,
******* KaVo expanded the recall to include the replacement cans with lot numbers ending in R3X via letters dated 2/26/07. The instructions and recall strategy remain the same as in the 11/22/06 letter, but requesting the dealers to notify their customers by 2/28/07. The QUATTROcare Spray will be replaced with Kavo Spray until the problem with the QUATTROcare Spray is resolved.
Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.
REASON The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
VOLUME OF PRODUCT IN COMMERCE 619,434 cans plus 23,088 replacement cans
DISTRIBUTION Nationwide and Canada

The spray was produced under the following labels:

a) KaVo QUTTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A

b) KaVo QUTTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUTTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A,
CODE All cans manufactured prior to 11/18/06 Replacement product will have a new date/lot code on the bottom of the can which will end in R3X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kavo America Corp, Lake Zurich IL
Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. F
REASON The QUATROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
VOLUME OF PRODUCT IN COMMERCE 619,434 cans
DISTRIBUTION Nationwide and Canada

PRODUCT Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet,
CODE Serial numbers in the following ranges: • NFD100006 - NFD100325H • NFD620017S - NFD625737S • NFD200201K - NFD201303K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN
Manufacturer: Medtronic Puerto Rico Operations Co., MedRel, Juncos, PR. F
REASON A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
VOLUME OF PRODUCT IN COMMERCE 6726 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411, CODE The lot number is always a six-digit number, where the first digits indicate the manufacturing sub-batch during the month and the last three digits indicate the month and year of the manufacture (MMY). The last three digits indicating month and year of manufacture are most significant. For example, a lot number ending in 086 indicates that this lot was manufactured in August 2006. -All lots manufactured in July, 2006 (076) or earlier are affected. -Compact Absorbers from lot numbers 133086 and 136086, manufactured in August, 2006, should be isolated and destroyed. All other lots manufactured in August 2006 (086) are acceptable for use. -All lots manufactured in September 2006 (096) or later are acceptable for use.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc., Madison WI,
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland.
REASON Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.
VOLUME OF PRODUCT IN COMMERCE 670,620 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188,
CODE Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI,
REASON The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
VOLUME OF PRODUCT IN COMMERCE 199 units
DISTRIBUTION Nationwide and Internationally

PRODUCT LIFEPAK 20 automatic external defibrillator,
CODE Devices with software version -028, -030, -032, and -038.
RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond WA,
REASON LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.
VOLUME OF PRODUCT IN COMMERCE 10,307 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007;
b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3650, Recall # Z- 0297-2007;
c) St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR
Model 5376; Pulse Generators (pacemakers),
CODE All Devices (all serial numbers for the devices referenced in the advisory.)
RECALLING FIRM/MANUFACTURER St Jude Medical CRMD, Sylmar, CA, REASON St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.
VOLUME OF PRODUCT IN COMMERCE 229,411 device
DISTRIBUTION Nationwide and Internationally

PRODUCT BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs,
CODE Catalog Number 3404001, serial number ranges: AI05070075 - AI05070099, AI05090000 - AI05090024, AI05110040 - AI05110059, AI05120000 - AI05120010, AI05120013 - AI05120024, AI06010035 - AI06010049, AI06040000 - AI06040024, AI06060000 - AI06060014, AI06060016 - AI06060024, AI06070035 - AI06070041, AI06070043 - AI06070045. Catalog Number 3401001S, serial number range: AI05110000 - AI05110039
RECALLING FIRM/MANUFACTURER Smiths Medical PM, Inc., Waukesha WI,
REASON An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.
VOLUME OF PRODUCT IN COMMERCE 207 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors.
Model numbers 4715319, 5206110, 5732388, and 7489375,
b) Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series
patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375,
c) Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit,
part number 7262814,
CODE All units installed or repaired prior to November 8, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA,
Manufacturer: Draeger Medical Systems Inc., Danvers, MA.
REASON Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
VOLUME OF PRODUCT IN COMMERCE 3556 units
DISTRIBUTION Nationwide

PRODUCT 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below,
CODE All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190
RECALLING FIRM/MANUFACTURER Varian Medical Systems Inc., Palo Alto CA,
REASON Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
VOLUME OF PRODUCT IN COMMERCE 1,689 Units
DISTRIBUTION Nationwide and Internationally