MAY 2003

 

WEEK ENDING MAY 3

 

PRODUCT Heat Exchanger Coil used in the "Custom Cardiovascular Procedure Kits".

CODE TCVS Product code number 0006-00011; all coils in custom cardiovascular procedure kits within their labeled shelf life of 24 months (i.e. kits made 12/1/2000 to 10/25/2002) as follows: Procedure Kit Codes Produced in Lot # 63182-02 CA02 70035; 8539TX CA07 62973; 63153;63688-01; 8539TX CA14 63688-01 CA14T 62973 CA28 8539TX CC04 63688-01; 8525T CC11 63688-01 CC11T 63688-01 CC11TR 62786; 62973;63432; 70060; 63688-01 CC18 63688-01 CC18T 63323-02; 63153 CC25 62336-01; 7957-02; 8525T CD04 63323-02 CD11 70035 ;8539TX; CD18 63182-02; 8525T CD25 62417-03; 62973-01; 63182-02; 63688-01 CE01 63688-01 CE01R 62973-01; 63688-01 CE01T 70187; 62786 CE08 70017; 62973-01 ;63182-02; 63688-01 CE15 63182-02; 63688-01 CE15T 63688-01 CE15TR 70001; 63182-02 CE22 63323-02 CE29 63432; 62336-01; 63079-01; 8525T; 63070-01; 63182-02 CF06 131246-01; 63014-01; 63688-01 CF13 63688-01 CF13R 63688-01 CF13T 70001; 63182-02 CF20 63323-02 CF28 63064 ;62336-01; 62544-01 CG03 63153; 70035; 62973-01 CG10 63064; 62417-03; 62973-01; 63688-01 CG17 63064 CG17R 63079-01; 63688-01 CG24 62336-01 CH01 62786; 63432;62973-01; 63688-01 CH08 62973-01 CH08T 70035; 63323-03; 63688-01 CH15 70001; 63688-01; 63182-02 CH22 63688-01 CH22T 63064; 70001; 70251; 131246-01; 63014-01 CH29 64130; 62544-01; 62973-01 CK05 64130 CK12 64130 CK12T 64130; 63079-01 CK19 63014-01; 63323-03 CK26 70085 CL03 62973-01; 8539TXC CL09 64203; 62973-01; 63064-01 CL16 70413; 8525T CL23 63298 YP04 62417-03 YP11 62336-01 YP18 63014; 8539TX ZA08 62973 ;8539TX ZA22 62973; 63079 ZA29 63432 ZC05 62973; 63014; 63432; 62513-01 ZC12 63014; 63079; 63298; 62973 ZC19 63153 ;63315; 63432; 62361-02; 62513-01 ZC26 62513-01 ZC26T 62786; 63315; 63323 ZD05 63064; 63323; 62544-01; 8525T; 62513-01 ZD12 62361-02; 62544-01; 63323 ZD19 63014 ;8539T; 62786 ZD26 62786; 63315 ZE02 63014; 63064; 63432; 8525T ZE09 63153; 62544-01; 63323 ZE16 62973 ;63323 ZE23 63014 ZE30 63064; 62417-03 ZF07 63064 ZF07R 62786; 63153 ZF14 62544-01; 8539TX ZF21 8539TX ZF21T 8539TX ZF21TR 62973; 63014; 63298 ZF29 62973; 63432; 63315-01 ZG04 62973; 8539TX ZG11 63323; 63079-01 ZG18 63323 ZG18T 62973; 63070; 63432; 62417-03; 63315-01 ZG25 63688; 70001; 63315-01; 8335TX ZH09 62973; 63688; 63079-01; 63153 ZH16 63688; 70001; 62336-01; 8525T ZH23 63688; 70001 ZH23T 63688; 63726; 8539TX ZH30 63688 ZH30R 63688 ZK06 63688 ZK06T 70012 ZK20 63014 ZK20R 70012 ZK20T 62786; 63079-01; 8525T; 8539TX ZK27 8539TX ZK27R 62786; 62973; 63014; 62417-03; 63323-01 ZL04 63014 ZL04R 62973 ZL04T 63014 ZL10 63014 ZL10T 8539TX; 8525T ZL17 62544-01; 63323-01; 8525T ZL24 63323-01 ZL24T 70073 ZM08 62786 ZM15 62786; 62417-03; 8525T ZM22 63014; 63688; 70085; 62336-01; ZM29 70085 ZM29R 62973; 63153; 63432; 63688 ZN05 62973 ZN05T 62973 ZN05TR 8539TX ZN12 8525T ZN19 62417-03; 62544-01 ZN26 62336-01 ;8525T; 63182-02 ZP03 8525T; 63182-02 ZP03T 63064; 63751;63815 ZP10 70106; 63182-02 ZP17.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems, Corporation, Ashland, MA,
REASON Heat exchanger may contain loose particulate matter.
VOLUME OF PRODUCT IN COMMERCE 10,035.
DISTRIBUTION Nationwide.

PRODUCT Biosound Caris Plus Ultrasound System with phased array probes, model 7230; Biosound Megas Ultrasound System with phased array probes, model 7250.
CODE All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes; All Megas units with PA122 or PA023 probes.
RECALLING FIRM/MANUFACTURER Biosound Esaote, Inc., Indianapolis, IN,
REASON Excessive power output due to a faulty voltage controller.
VOLUME OF PRODUCT IN COMMERCE 157 Caris Plus systems; 503 Megas.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT Sedecal High Voltage Generators and Sedecal Controls.
CODE Model Number:а US Distributed -
SHF210 (6); SHF310 (70); SHF310RF (2); SHF310LS (3); SHF310AEC (1); SHF310PSU (3); SHF320 (30); SHF320F (1); SHF320RF (1); SHF320LS (1); SHF330 (5); SHF410 (7); SHF410RF (1); SHF420 (4); SHF420RF(2); SHF430RF (1); SHF510 (5); SHF510LS (2); SHF520 (4);
SHF520RF (3); SHF520LS (1); SHF525RF (2); SHF530 (1); SHF530LS (1); SHF535 (4); SHF625 (1); SHF630 (3); SHF630RF (2); SHF635 (1); SHF835 (2); SHF835RF(2).
Foreign Distributed -
SHF310 (9); SHF315 (1); SHF320 (6); SHF320RF(2); SHF320-CE(4); SHF330 (1); SHF410 (1); SHF420RF(1); SHF520 (1); SHF630 (1).
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal US, Inc, Arlington Heights, IL,
Manufacturer: Sedecal SA, Madrid, Spain.
REASON An incorrect identification label and the failure of the certification testing program resulted in Generators and High Voltage Controls not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 199 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Sedecal Mobile X-Ray System.
CODE Model Numbers: SM20H and SM30H.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal US, Inc, Arlington Heights, IL,.
Manufacturer: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing.
REASON An incorrect identification label and the failure of the certification testing program resulted in the Mobile Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION Nationwide and Germany.

PRODUCT Sedecal URS X-Ray System.
CODE Model Number: URS.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, .
Manufacturer: Sedecal SA, Madrid, Spain.
REASON An incorrect identification label and the failure of the certification testing program resulted in the Sedecal URS X-Ray Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NY, TX, FL, and MN.

PRODUCT Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250.
CODE All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.
RECALLING FIRM/MANUFACTURER Deroyal Surgical-Rose Hill, Rose Hill, VA,

REASON Non-sterile surgical medical device is labeled as sterile product.
VOLUME OF PRODUCT IN COMMERCE 216 units.
DISTRIBUTION PA, TX, WA, AR, HI, CA, and TN.


PRODUCT Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936.
CODE Lot numbers: 262111 (manufactured June 2002, expires May 2005); 282233 (manufactured August 2002, expires July 2005).
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA,

REASON Wrong component may result in over infusion of medications.
VOLUME OF PRODUCT IN COMMERCE 5,808 units.
DISTRIBUTION NY, MA, and Internationally.

PRODUCT Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250.
CODE Lot number 5140999.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN,

REASON The product units in the recalled lot are in pouches which may have incomplete seals that could lead to compromised sterility.
VOLUME OF PRODUCT IN COMMERCE 31 stents.
DISTRIBUTION Nationwide.

PRODUCT
a) Multi Absorbers, reference number 8003138.
b) Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers).

CODE
a) Lot numbers 728112 and 798122;
b) Lot numbers 728112 and 798122 of the Multi Absorbers in the kits.
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Madison, WI,
REASON Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
VOLUME OF PRODUCT IN COMMERCE
a)167 cases (6 Multi Absorbers per case);
b) 5 S/5 Aespire Start-up kits.
DISTRIBUTION Nationwide.

PRODUCT
a) Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133, and 3000141.
b) Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
CODE All lots.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN,
REASON Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
VOLUME OF PRODUCT IN COMMERCE 10,600,000 vials.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec.
CODEа Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809.
RECALLING FIRM/MANUFACTURERа Linvatec Corp., DBA Linvatec/Hal, Largo, FL.,

REASON The Footswitch functions of the left and right foot pedals may be reversed in some units.
VOLUME OF PRODUCT IN COMMERCE 74 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT CryoValve Allograft, Heart Valve.
CODE Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA,

REASON Pre-processing cultures detected certain microorganisms in donor tissue.
VOLUME OF PRODUCT IN COMMERCE 2 individual heart valve allografts.
DISTRIBUTION OH and Canada.

PRODUCT CoaguChek PT test strips, sold in 12 pack.
CODE Lot 533.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN,
REASON Discrepancy between INR and the % Quick displayed on the meter.
VOLUME OF PRODUCT IN COMMERCE 11,412.
DISTRIBUTION Germany.

PRODUCT
a) CryoValve Heart-valve, allograft.
b) CryoValve Heart-valve, allograft.
CODE a) Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695,
Serial #6356214, Model #PV00;
b) Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695,
Serial #6356214, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA,
REASON The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
VOLUME OF PRODUCT IN COMMERCE 2 allografts.
DISTRIBUTION NY and MS.

PRODUCT Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. CODE No codes.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON Under certain operating conditions, smart wash feature disables with multiple samples.
VOLUME OF PRODUCT IN COMMERCE 645 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350.
CODE Lot number 89651M300, exp. 04/20/03.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL,

REASON The Imx AFP Calibrators may cause depressed values for the Imx AFP Low Control, and cause patient results to be 20% lower than actual values.
VOLUME OF PRODUCT IN COMMERCE 107 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; the product is packaged in 5-gallon pails under the W.R. Grace label.а
b) Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; the product is packaged in pre-packs(pre-filled 2.5 lb. canisters, 12 per carton), canister packs (pre-measured
2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label.

CODE a) Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05;
b) Lot numbers CN12-P115-02, CN12-P115-03, CN12-P115-04, CN12-P115-05, CN12-P115-07, CN12-P115-08, CN12-P115-09, CN12-P115-10, CN12-P115-11, CN12-P115-12, CN12-P115-13, CN12-P115-14, CP01-P115-01, CP01-P115-02, CP01-P115-03, CP01-P115-04, CP01-P115-05, CP01-P115-08, CP01-P115-10, CP01-P115-11, CP01-P115-12, CP01-P115-15, CP01-P115-16, CP01-P115-17, CP01-P115-18, CP01-P115-19, CP01-P115-20,
CP01-P115-21, CP01-P115-22 and CP01-P115-23.
RECALLING FIRM/MANUFACTURER Recalling Firm: Darex Container Products, Div of W. R. Grace & Co, Chicago, IL,

Manufactured by: W.R. Grace & Company, Chicago, IL. Firm initiated recall is ongoing.
REASON Contaminated with epoxy chips.
VOLUME OF PRODUCT IN COMMERCE
a) 32,232 pre-packs; 50,748 canister packs; 1,400 5 gallon pails; 49 55 gallon drums.
b) 591 5 gallon pails.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, Contents Sterile.
CODE Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
RECALLING FIRM/MANUFACTURER C. R. Bard, Inc., Urological Division, Covington, GA,

REASON There is a potential for package seals to b open after sterilization.
VOLUME OF PRODUCT IN COMMERCE 283, 277 units.
DISTRIBUTION Nationwide.


PRODUCTа Finger Joint Implants, Silicone Models
a) TRL-10 and b) TRL-20.
CODE
a) Lot 45275002;
b) Lot 45186001.
RECALLING FIRM/MANUFACTURERа Avanta Orthopaedics, Inc., San Diego, CA,
REASON Wrong silicone elastomer used in construction.
VOLUME OF PRODUCT IN COMMERCE a) 13 units; b) 30 units.
DISTRIBUTION CA, UT, and France.

 

PRODUCT Gluteraldehyde Concentration Indicators.
a) MetriTest 1.5%;
b) MetriTest 1.8%;
c) OmniChek 1.5%;
d) OmniCheck 1.8.
CODE a) MetriTest 1.5%, part number 10-303, lot numbers: 007917, 007919, 008184, 008325, 008665, 009100;
b) MetriTest 1.8%, part number 10-304, lot numbers: 009101, 009121, 009144, 009249;
c) OmniChek G 1.5%, part number 10-313, lot 009091;
d) OmniChek G 1.8%, part number 10-313, lot 009102.
RECALLING FIRM/MANUFACTURER Sybron Dental Specialties, Orange, CA,.
REASON Moisture ingress into packaging of test strips may cause premature failure.
VOLUME OF PRODUCT IN COMMERCE 4,112 cases.
DISTRIBUTION Nationwide and Canada.

PRODUCT ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems.
CODE All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
RECALLING FIRM/MANUFACTURERа Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL,

REASON ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
VOLUME OF PRODUCT IN COMMERCE 600 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT 3 M Attest Steam Pack 1276F (biological indicator of steam sterilization for use at hospitals).
CODE Lot 2330-06 AE.
RECALLING FIRM/MANUFACTURER 3m Health Care, Saint Paul, MN, by letter on January 8, 2002.
REASON Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
VOLUME OF PRODUCT IN COMMERCE 666 cases (25 Steam Pack per case).
DISTRIBUTION Nationwide.

 

WEEK ENDING MAY 10

 

PRODUCT TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit.
CODE Serial numbers 0550037 through 0559399.
RECALLING FIRM/MANUFACTURER Kinetic Concepts, Inc., San Antonio, TX,

REASON Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
VOLUME OF PRODUCT IN COMMERCE 4,264 Units.
DISTRIBUTION Nationwide.


PRODUCT a) Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 400-200.
b) Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201.
c) Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-2003.
d) Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x70 cm) Product Number: 400-211.
e) Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x70 cm) Product Number: 400-212.
f) Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-213.
g) Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202.
CODE
a) Lot Numbers: 5178407 5202076 5275909 5309468 5337024;
b) Lot Numbers: 5178078 5180218 5195624 5198454 5202074 5205547 5208877 5215596 5218848 5225787 5228124 5229087
5230642 5238639 5241768 5243189 5243190 5246163 5252047 5252048 5252049 5253538 5256810 5259786 5269989 5291570
5303658 5315933 5315934 5326181 5326182 5327127 5331373 5334828 5337025 5337026 5344010 5345288 5355951 5358877;
c) Lot Numbers: 5225786 5303820 5312170 5340602;

d) Lot Numbers: 5178119 5188905 5192526 5192527 5194308 5198455 5202075 5205549 5208875 5208878 5225910 5226327
5229088 5235251 5235252 5235253 5258360 5258361 5269990
5270281 5286299 5288682 5291571 5291572 5315936 5327922 5331374 5334829 5334830 5337023 5344015 5363071
5366442 5366443 5375808 5381688;
e) Lot Numbers: 5180479 5188907 5222243 5253537 5296860 5309467 5345287 5369860;
f) Lot Numbers: 5218586 5303655 5312172 5348155;а
g) Lot Numbers: 5161012 5174860 5174861 5180481 5185487 5218431 5221729 5243192 5252957 5296861 5296862 5303657
5327920 5327921 5345290 5348157 5355947.

RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA,
REASON Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use.
VOLUME OF PRODUCT IN COMMERCE 715 boxes.
DISTRIBUTION Nationwide, Singapore, Japan, Korea, Canada, and Africa.

PRODUCT Easypump LT 6024 Easypump InfusionPump (60 ml x 22 ml/hr).
CODE Lot numbers 04434366/2A2469 and 04434367/2A2470.
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA,.
REASON Overinfusion due to misassembly.
VOLUME OF PRODUCT IN COMMERCE 2,638 units.
DISTRIBUTION France.

PRODUCT a) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-
219226.
b) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266.
c) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228316.
d) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #:8888-219220.
e) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26 cm Venous Cuff Code #: 8888-223260.
f) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228310
CODE All codes.
RECALLING FIRM/MANUFACTURER Tyco Healthcare/Kendall, Mansfield, MA,

REASON Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter.
VOLUME OF PRODUCT IN COMMERCE 1,077 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT a) TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds.а
b) KinAir IV TheraPaulse II AC-Powered Adjustable Hospitalа Beds.
c) BariAir AC-Powered Adjustable Hospital Beds.
d) PediDyne AC-Powered Adjustable Hospital Beds.
e) TransportAir Auxiliary Blower Unit.
CODE All Serial Numbers.
RECALLING FIRM/MANUFACTURER Kinetic Concepts, Inc., San Antonio, TX,
REASON Battery Failure/Outgassing.
VOLUME OF PRODUCT IN COMMERCE
a) 915 units;
b) 381 units;
c) 237 units;
d) 244 units;
e) 9,399 units.
DISTRIBUTION Nationwide.

PRODUCTа Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label.
a) Major Pack.
b) RJT&A Pack.
c) T & A Pack.а
d) Back Pack.
e) Arthroscopy Pack.
f) Cloward Pack.
g) Dr Desai's Pack.
h) Abdominal Gyn Pack.
i) Shoulder Pack.
j) Knee Pack.
k) Craniotomy Pack.
l) Laminectomy Pack.
m) Knee Arthroscopy Pack.
n) Shoulder Arthroscopy.
o) Lami Lap Pack.
p) Band Bag W/Fastener.
q) Band Bag.
r) Pick Up Pack.
s) Penrose Ace Bandage.
t) Subclavian Procedure Tray.
u) Isolation Gown Pack.
v) Valve Accessory Pack.

CODE a) Catalog number 002117-000 Lot numbers 000006595 000006895;
b) Catalog number 002142-000 Lot numbers 000006010, 000005754;
c) Catalog number 002612-000 Lot numbers 000006693, 000006858;
d) Catalog number 002199-000 Lot numbers 000005267, 000006020, 000006280;
e) Catalog number 002238-000 Lot number 000006601;
f) Catalog number CPA-2374 Lot numbers 007253692, 000000329, 000000644, 000001197, 000001988, 000002422, 000002854, 000003293, 000003400, 000004000, 000004498, 000004845, 000005665, 000005763, 000005783, 000006309, 000006530, 000006766;
g) Catalog number CPA-3064 Lot numbers 000005461, 000005613, 000005829, 000005854, 000006093, 000006210, 000006226, 000006427;
h) Catalog number CPA-2378 Lot numbers 000002809,
000003401, 000003647, 000004421, 000004844, 000005838,
000006012;
i) Catalog Number 002617-000 Lot number 000006848;
j) Catalog number 002618-000 Lot numbers 000006700, 000006897;
k) Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505;
l) Catalog Number CPA-2390 Lot Numbers 007253617, 007253618, 000000151, 000000426, 000000536, 000001201, 000001517, 000001772, 000001961, 000002108, 000002109, 000002409, 000002588, 000002589, 000002907, 000002908, 000003429, 000003430, 000003738, 000003739, 000004355, 000004356, 000004802, 000004803, 000005460, 000005506, 000005825, 000005786, 000006248, 000006410, 000006532;

m) Catalog Number CPA-3398 Lot Number 000005563, 000005677, 000005875, 000005974, 000006112, 000006232;
n) Catalog Number CPA-3400 Lot Numbers 000005595, 000005706, 000005927, 000006113;
o) Catalog Number CPA-3557 Lot Numbers 000006892, 000006893;
p) Catalog Number CPA-50009 Lot numbers 000000875, 000000876, 000000877, 000000878, 000000879, 000000880, 00000881, 000000882, 000000883, 000000884, 000000885, 000000886, 000000887, 000000888, 000000889, 000000890, 000000891, 000000892, 000000893, 000000894, 000001235, 000001236, 000002011, 000002012, 000003160, 000003161, 000003162, 000005535, 000005939, 000006004;
q) Catalog Number CPA-50025 Lot Numbers 007253627, 007253628, 007253629, 007253630, 007253631, 007253632, 007253633, 007253634;
r) Catalog Number CPA-3410 Lot Numbers 000005222, 000005442, 000005223, 000005224, 000006330, 000006294;
s) Catalog Number CPA-3294 Lot Numbers 000000819, 000000820, 00001431, 000001432, 000002405, 000002533, 000002755, 000003124, 000003125, 000004077, 000004189, 000004657, 000004658, 000005472, 000005979;
t) Catalog Number CPA-1069 Lot Numbers 000000668, 000000669, 000000670, 000000672, 000000673, 000000674, 000000676, 000000677, 000000671, 000000675, 000000678, 000000679, 000000681, 000000682, 000000683, 000000684, 000000692, 000000693, 000000694, 000000695, 000000696, 000000697, 000000698, 000000699, 000000709, 000000713, 000000716, 000000717, 000000720, 000000724, 000000725, 000000728, 000000732, 000000733, 000000734, 000000735, 000000736, 000000737, 000000680, 000000685, 000000686, 000000687, 000000688, 000000689, 000000690, 000000691, 000000700, 000000701, 000000702, 000000703, 000000704, 000000705, 000000706, 000000707, 000000708, 000000710,
000000711, 000000712, 000000714, 000000715, 000000718, 000000719, 000000721, 000000722, 000000723, 000000726, 000000727, 000000729, 000000730, 000000731, 000005001, 000005002, 000005003, 000005004, 000005005, 000005006, 000005007, 000005008, 000005009, 000005010, 000005014, 000005015, 000005016, 000005021, 000005022, 000005025, 000005026, 000005027, 000005029, 000005030, 000005031, 000005032, 000005011, 000005012, 000005013, 000005017, 000005018, 000005019, 000005020, 000005023, 000005024, 000005028, 000005033, 000005034, 000005035;
u) Catalog Number CPA-1431 Lot Numbers 000000848, 000000849, 000002055, 000002828, 000002829, 000004637, 000004638;
v) Catalog Number CPA-3648 Lot Numbers 000004282, 000005469, 000005896, 000005639, 000006725.
RECALLING FIRM/MANUFACTURER Windstone Medical Inc., Billings, MT,

REASON Product has latex free symbol on package, yet contains latex components.
VOLUME OF PRODUCT IN COMMERCE 7,958 packs.
DISTRIBUTION CO, IN, MI, MN, MT, UT, and WA.

PRODUCT Guidant Multi-Link Vision Coronary Stent System. Catalog Numbers: 30 different catalog numbers have been listed.
CODE All lots are included in the action.
RECALLING FIRM/MANUFACTURER Guidant Corporation ACS, Temecula, CA,

REASON Complaints that the stents are being dislodged from the delivery system.
VOLUME OF PRODUCT IN COMMERCE Estimated 7 to 9 thousand units.
DISTRIBUTION Internationally.

PRODUCT a) Boston Scientific Scimed Radius Monorail 4.0 mm Stent Systems, Catalog Number H74917485400.
b) Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301.
c) Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401.
CODE
a) Lot number 5350420;
b) Lot number 5357125;
c) Lot number 5350197.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN,

REASON A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
VOLUME OF PRODUCT IN COMMERCE 12 stent systems.
DISTRIBUTION Nationwide.

PRODUCTа Vision Hollow Fiber Oxygenator.
CODE Lot 205200.
RECALLING FIRM/MANUFACTURER Gish Biomedical, Inc., Rancho Santa Margarita, CA,

REASON Two reports of leakage.
VOLUME OF PRODUCT IN COMMERCE 1,749.
DISTRIBUTION Nationwide, Austria, Canada, Japan, and Saudi Arabia.

 

WEEK ENDING MAY 24


PRODUCT Portable HDX Dental X-Ray System.
CODE All Portable HDX Systems manufactured and distributed from August 2000 through July 2002 are included in this CAP.
RECALLING FIRM/MANUFACTURER DentalEZ (StarDental), Lancaster, PA,
REASON The Portable HDX Intraoral Dental X-Ray Systems contained a noncompliant date format on the labels and the serial number and date on the labels of were not legible.
VOLUME OF PRODUCT IN COMMERCE 231 units.
DISTRIBUTION Nationwide.

PRODUCT Sedecal X-Ray High Voltage Generators and Controls.
CODE Model SHF210, serial numbers G13360, G13782, G13810, G13812, G13814, G13815; Model SHF310, serial numbers G13058, G13269, G13335, G13336, G13361, G13364, G13367, G13430, G13536, G13441, G13442, G13550, G13553, G13577, G13587, G13591, G13595, G13605, G13648, G13651, G13653, G13656, G13790, G13800, G13822, G13854, G13855, G13856, G13868, G13930, G13932, G14023, G14029, G14032, G14034, G14035, G14037, G14038, G14039, G14321, G14325, G14326, G14328, G14332, G14391, G14394, G14558, G14576, G14577, G14581, G14584, G14585, G14675, G14727, G14731, G14734, G14736, G14737, G14738, G14740, G14767, G14768, G14780, G14781, G14782, G14785, G14786, G14820, G14821, G14794, G14795, G14796, G14798, G14800, G14837, G14850, G14873, G14874, G14989; Model SHF310RF, serial numbers G13404, G13547; Model SHF310LS, serial numbers G13405, G13429, G14354; Model SHF310AEC, serial number G14028; Model SHF310PSU, serial numbers G14359, G14569, G14607; Model SHF315, serial number G14926; Model SHF320, serial numbers G13314, G13437, G13453, G13467, G13476, G13483, G13491, G13524, G13525, G13544, G13551, G13556, G13558, G13560, G13563, G13718, G13722, G13738, G13739, G13806, G13809, G13813, G13816, G13823, G13944, G13946, G13956, G13957, G14271, G14274, G14367, G14762, G14763, G14829, G15019, G15023; Model SHF320F, serial number G13270; Model SHF320RF, serial numbers G14016, G14019, G14027; Model SHF320CE, serial numbers G14453, G14455, G14847, G14853; Model SHF320LS, serial number G14051; Model SHF330, serial numbers G13303, G14171, G14249, G14324, G14343, G14969; Model SHF410, serial numbers G13357, G13537, G13992, G14037, G14053, G14313, G14328, G14813; Model SHF410RF, serial number G14538; Model SHF420, serial numbers G13760, G14013, G14269, G14329; Model SHF420RF, serial numbers G14047, G14621, G14885; Model SHF430RF, serial number G14620; Model SHF510, serial numbers G14490, G14529, G14668, G14876, G14904; Model SHF510LS, serial numbers G14167, G14169; Model SHF520, serial numbers G13527, G13581, G13704, G14210, G14317; Model SHF520RF, serial numbers G14317, G14669, G14881; Model SHF520LS, serial number G13918; Model SHF525RF, serial numbers G14248, G13251; Model SHF530, serial number G13574; Model SHF530LS, serial number G14728; Model SHF535, serial numbers G13233, G13273, G14869, G14869; Model SHF625, serial number G13378; Model SHF630, serial numbers G13230, G14345, G14670, G14971; Model SHF630RF, serial numbers G14392, G14747; Model SHF635, serial number G14395; Model SHF835, serial numbers G13724, G14507; Model SHF835RF, serial numbers G13240, G13240.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, .
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing.
REASON Incorrect identification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 199 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Easy Moving Motor Driven Mobile X-Ray Unit,
a) Model SM-20HF.
b) Model SM-30HF.
CODE a) Model SM-20HF, serial numbers G13487, G13457;
b) Model SM-30HF, serial numbers G12468, G13449,
G13540, G13747, G13765, G14097, G14099, G14633, G15025.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL,
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN.а
REASON Incorrect identification labels and failure of the certification testing resulting in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION NC, LA, NY, NJ, MO, KY, TX, and Germany.

PRODUCT Optima URS X-Ray System.
CODE Serial numbers G14698, G14689, G14501, G14932, and G14835.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal USA. Inc., Arlington Heights, IL,
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing.
REASON Incorrect identification labels and their dertification testing program failed in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NY, TX, FL, and MN.

PRODUCT Halo Support Bracket Assembly (Part # 438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.
CODE Lot # 031 - etched on the side of the Clamp Assembly.
RECALLING FIRM/MANUFACTURER Ohio Medical Instrument Co, Inc., Cincinnati, OH,
REASON The component was manufactured with an insufficient weld that could break during use.
VOLUME OF PRODUCT IN COMMERCE 32 components.
DISTRIBUTION NY, NJ, IL, FL, Japan, Hong Kong, Korea, Great Britain, and Germany.

PRODUCT Architect Progesterone Reagent Kit:
a) List 6C26-27 (100 tests);
b) List 6C26-22 (400 tests). .
CODE a) Lot 95651M201;
b) Lots 95651M200, 95651M202.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park, IL,
REASON Lot gives lower specimen results compared to results generated with other lots.
VOLUME OF PRODUCT IN COMMERCE 368 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT a) MAC-LAB 1000EX systems.
b) MAC-LAB 3000EX systems.
c) MAC-LAB 5000EX systems.
d) MAC-LAB (Classic) systems.

CODE The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee, WI,
REASON There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
VOLUME OF PRODUCT IN COMMERCE 1,330 devices.
DISTRIBUTION Nationwide, and Internationally.

PRODUCTа AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
VOLUME OF PRODUCT IN COMMERCE 645 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Vicks brand Warm Mist Humidifier, Model V610, "Pure warm moisturizer for soothing relief of cold and flu symptoms" sold over the counter.
CODE 8-digit code ending in either 2KUO or 3KUO.
RECALLING FIRM/MANUFACTURER KAZ, Inc, Hudson, NY,
REASON Humidifiers may overheat.
VOLUME OF PRODUCT IN COMMERCE 110,000 units.
DISTRIBUTION Nationwide.

PRODUCT Phillips ADAC brand C-PET and Allegro Imaging Systems.
CODE DICOM 3.0, C-PET rev. 7.3.5: SW-CD-UGM-7.3.5 rev. 1; DICOM 3.0, Allegro rev. 8.0.1: SW-CD-UGM-8.0.1rev. 0.
RECALLING FIRM/MANUFACTURER Phillips ADAC Milpitas, CA,
REASON Resulting images may be labeled incorrectly on PETView and receiving system.
VOLUME OF PRODUCT IN COMMERCE 104.
DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING MAY 31

 

PRODUCT Misys Laboratory System.
CODE Versions 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ,
REASON With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.
VOLUME OF PRODUCT IN COMMERCE 463.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version.
b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9 Software Version. а
c) Gemstar_ Therapy Pain Management I.V. Infusion Pump, List#: 13150-04; 2.9 Software Version.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Morgan Hill, CA,
REASON Products contain software deficiencies which could allow over infusion thereby administering excess medication.
VOLUME OF PRODUCT IN COMMERCE 1,310 units.
DISTRIBUTION Nationwide.

PRODUCT Vacuette Safety Blood Collection Set with Luer Adapter.
CODE Item number 450096, Lot #'s 02109C, 02111C, and 02120C.
RECALLING FIRM/MANUFACTURER Greiner VACUETTE North America, Monroe, NC,
REASON The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
VOLUME OF PRODUCT IN COMMERCE 139,000 units.
DISTRIBUTION Nationwide.

PRODUCT Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
CODE All units distributed since product introduction in December 2002 are involved.
RECALLING FIRM/MANUFACTURER Deltec, Inc., St Paul, MN,
REASON A software error can result in the delivery of a larger bolus of insulin than anticipated when the pump is programmed in a particular manner.
VOLUME OF PRODUCT IN COMMERCE 913 pumps.
DISTRIBUTION Nationwide.

PRODUCT Anti-HBs Reagent Kit, 100 tests.
CODE List 7C18-25, lot 95305M200.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL,
REASON Particulate matter in the microparticle component.
VOLUME OF PRODUCT IN COMMERCE 289 kits.
DISTRIBUTION Canada, Germany and Japan.

PRODUCT Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; part code: SN4.
CODE All units distributed between 1/3/01 and 3/10/03.
RECALLING FIRM/MANUFACTURER Hu-Friedy Mfg., Co., Inc, Chicago, IL,
REASON The suture needles were mislabeled with the wrong size.
VOLUME OF PRODUCT IN COMMERCE 200 vials.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Misys Laboratory System.
CODE Versions 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, а
REASON Software anomaly may result in incorrect values and interpretations.
VOLUME OF PRODUCT IN COMMERCE 463.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Twister (tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
CODE Lots IA702, II327, IK454, and IM236.
RECALLING FIRM/MANUFACTURER Action Products Incorporated, Hagerstown, MD,
REASON Stitching in wheelchair seat back is not effective and may not support user.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT a) CoaguChek Pro DM meter; catalog # 1894048, and 1893211.
b) CoaguChek Plus meter; catalog # 4757298, and 12816001.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN,
REASON High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
VOLUME OF PRODUCT IN COMMERCE 1,794.
DISTRIBUTION Nationwide.

PRODUCT Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. а
CODE All frames manufactured since the product was released are suspect.
RECALLING FIRM/MANUFACTURER Ossur North America, Inc., Aliso Viejo, CA,
REASON Knee frame defect led to breakage and injury. Knee bolt end came loose.
VOLUME OF PRODUCT IN COMMERCE 261.
DISTRIBUTION Nationwide.

PRODUCT Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
CODE Lot 2005-02-17. Exp. February 2005.
RECALLING FIRM/MANUFACTURER Aspen Surgical Products, Inc., Bryon Center, MI,
REASON Sterility compromised - incomplete sterile package seal.
VOLUME OF PRODUCT IN COMMERCE 299 boxes.
DISTRIBUTION Nationwide, Japan and United Kingdom.

PRODUCT a) C1141 Flexible Endoscope Processing Container, Designed to fit the Steris System I Processor. The unit may be sold
individually or with the processing tray assembly (C1140).
b) C1140 Flexible Endoscope Processing Container and Tray assembly.
CODE All codes.
RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH,
REASON The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
VOLUME OF PRODUCT IN COMMERCE 492 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr.
CODE Catalog No. 8908. Lot Number: 5248945.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA,
REASON Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION CA, FL, MA, ME, MI, NC, PA, and WV.

PRODUCT Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora.
CODE Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL,

REASON The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
VOLUME OF PRODUCT IN COMMERCE 25,014 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Permobil Chairman 2K powered wheelchair.
CODE аSerial numbers: 1100155 to 1102472 and 4100019 through 4100225.
RECALLING FIRM/MANUFACTURER Permobile, Inc., Lebanon, TN,
REASON One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
VOLUME OF PRODUCT IN COMMERCE 1,319.
DISTRIBUTION Nationwide, Canada, and Puerto Rico.

PRODUCT SHPI LiftLoc Safety Infusion Sets.

CODE Product Code - Lot #: 0661934- 36ANHP01; 0662034 - 36ANHP02; а0662234 - 36ANHO03; 0661910 -36ANHP04; 0661915 - 36ANHP04;
0661915 -36ANHP06; 0662015 - 36ANHO7; 0662215 -36ANHP08; 0662010- 36ANHP09; 0641910 -36ANHP10; 0642234 -36ANHP11;
0642210 - 36ANHP12; 0641934 -36ANHP13; 0642034 -36ANHP14; 0642010 -36ANHP15; 0614915 -36ANHP16; 0642015 -36ANHP17;
0642210 -36ANHP19; 0642234 -36ANHP20; 0641910 -36ANHP21.
RECALLING FIRM/MANUFACTURER Specialized Health Products, Inc, Bountiful, UT,
REASON Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 29,120 units.
DISTRIBUTION UT.

PRODUCT a) 3M Ioban 2 Antimicrobial Incise Drapes.
b) 3M Ioban 2 Antimicrobial Incise Drapes.

CODE a) Model 6648EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and
February 28, 2003, were recalled.
b) Model 6651EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and
February 28, 2003, were recalled.
RECALLING FIRM/MANUFACTURER 3m Health Care, Saint Paul, MN, а
REASON The product does not meet its specifications for iodine content, and has the possibility of causing moderate short-term skin irritation if used.
VOLUME OF PRODUCT IN COMMERCE 8,702 drapes.
DISTRIBUTION Nationwide.

PRODUCT a) Leonardo MM-WS systems. System, Image Processing.
b) Smatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
CODE a) Model Number 7129534; b) Model Number 7393114.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.

REASON Perfusion CT is displaying a higher gray and color values than normal. A software problem.
VOLUME OF PRODUCT IN COMMERCE 3.
DISTRIBUTION OH, MA, and MO.


PRODUCT a) ARCHITECT I System External Waste Pump.
b) AEROSET System External Waste Pump.
CODE a) Product List Number 8C94-99, no lot numbers or codes;
b) Product List Number 9D61-01, no lot numbers or codes.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
VOLUME OF PRODUCT IN COMMERCE 1,779 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT a) Z2 Guiding Catheter 6 F JL3.5 SH Item No.: Z26JL35SH.
b) Z2 Guiding Catheter 6 F JR3.5 SH Item No.: Z26JR35SH.
CODE a) and b) Lot Number: 122596.
RECALLING FIRM/MANUFACTURER Medtronic, Inc, Danvers, MA,
REASON The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right) of the catheter may not correctly match the box label.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION Nationwide, Japan, and Hungary.


PRODUCT Aeroset Direct HDL Reagent, LN 7D67-01.
CODE Lot 86027HW00, Exp. Date May 14, 2003; Lot 89150HW00, Exp. Date September 13, 2003.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div., South Pasadena, CA,
REASON Degradation prior to expiry date.
VOLUME OF PRODUCT IN COMMERCE 1409
DISTRIBUTION Nationwide, and Internationally.


PRODUCT COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use.
CODE All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA,
REASON Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
VOLUME OF PRODUCT IN COMMERCE 98.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT Misys Commercial Laboratory, Laboratory Information System.
CODE Version 3.4.1.
RECALLING FIRM/MANUFACTURER Misys Healthcare System, Plano, TX,
REASON Software logic error. Dates were printing incorrectly on cumulative reports.
VOLUME OF PRODUCT IN COMMERCE 1.
DISTRIBUTION SC.

 

PRODUCT Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2. The product is packaged and distributed as 15 and 30 packs.
CODE Focus Dailies Toric 15 lens pack (Cylinder 10.75/Axis 90вк): Sphere -1.00, Lot 2298508; Sphere 1.25, Lot #2298512, 2304513; Sphere -1.50, Lot #2298509, 2304510; Sphere -1.75, Lot #2304512, 2304522 and Sphere -2.00, Lot #2298510. Focus Dailies Toric 30 lens pack (Cylinder -0.75/Axis 90вк): Sphere -1.00, Lot #2298475, 2295481, 2298497, 2304509, 2304519, 2304529; Sphere -1.25, Lot #2298480, 2298485, 2298502, 2304523, 2304533; Sphere -1.50, Lot #2298476, 2298482, 2298498, 2304520, 2304530; Sphere -1.75, Lot #2298479, 2298484, 2298501, 2298511, 2304532 and Sphere -2.00, Lot #2298478, 2298483, 2298499, 2304511, 2304521, 2304531.
RECALLING FIRM/MANUFACTURER Ciba Vision Corporation, Duluth,
REASON Lenses may be labeled with the incorrect axis.
VOLUME OF PRODUCT IN COMMERCE 8,572 packs (181,440 lenses).
DISTRIBUTION Nationwide, Canada, and Europe.


PRODUCT BD First PICC 3F 65 cm Single Lumen Procedure Kit.
CODE Reference No. 384134, Lot No. 2326770.
RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy, Sandy, UT,
REASON A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
VOLUME OF PRODUCT IN COMMERCE 840 kits.
DISTRIBUTION Nationwide.

PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
CODE a) Serial Numbers: 3094 through 3196; b) Serial Numbers: 8008 through 8069.
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Highland Heights, OH,
REASON Patient images may be stored in the archive directory of a different patient.
VOLUME OF PRODUCT IN COMMERCE a) 137 units; b) 50 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT MagicView 1000 and Magic View Mondo. Digital Image Communication.
CODE Serial Numbers: 1017; 1030; 1052; 1053; 1054; 1063; 1066; 1085; 1086; 1052; 1060; 1085; 1088; 1090; 1091; 1093; 1096; 1099; 1100; 1101; 1102; 1104; 1105; 1106; 1109; 1114; 1116; 1119; 1126; 1127; 1133; 1134; 1135; 1136; 1137; 1138; 1139; 1145; 1148; 1149; 1150; 1151; 1152; 1153; 1154; 1155; 1156; 1161; 1165; 1168; 1171; 1172; 1173; 1174; 1177; 1186; 1187; 1189; 1246; 1262; 1265; 1266; 1268; 1271; 1274; 1275; 1293; 1294; 1295; 1296; 1297; 1300; 1301; 1309; 1310; 1318; 1323; 1324; 1326; 1328; 1333; 1336; 1341; 1343; 1344; 1346; 1347; 1356; 1366; 1367; 1368; 1369; 1373; 1374; 1375; 1376; 1377; 1381; 1382; 1383; 1384; 1385; 1386; 1387; 1388; 1390; 1391; 1395; 1396; 1399; 1402; 1406; 1410; 1427; 1428; 1441; 1442; 1445; 1452; 1453; 1454; 1455; 1456; 1457; 1458; 1459; 1460; 1461; 1462; 1464; 1467; 1468; 1470; 1471; 1472; 1481; 1485; 1497; 4109; 4111; 4138; Govt. accounts: 1031; 1057; 1062; 1098; 1108; 1162; 1167; 1169; 1254; 1255; 1303; 1320; 1404; 1429; 1478; 1488; 1592; 1730.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA,
REASON Potential error can occur with the 3D post processing options MPR, MIP, and VRT. If a very large series are loaded into the 3D application, the scan range is not displayed entirely in the reconstruction.
VOLUME OF PRODUCT IN COMMERCE 159 units.
DISTRIBUTION Nationwide.