SEPTEMBER 2001

WEEK ENDING SEPTEMBER 1

 

PRODUCT AND CODE: Revo Scooter. The product is a three wheeled motorized scooter. The product has been designed for both indoor and outdoor use to clean and dry conditions. Model Information: SC60RRED, SC60RBLU, and SC60RYELModels: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow)

REASON: Scooter drive system may engage while parking brake is inactive.

MANUFACTURER: Shanghai Global Fabtech Plastic Products, Shanghai, China,

RECALLED BY: Pride Mobility Products Corp, Exeter, PA

DISTRIBUTION: Nationwide and Canada

QUANTITY: 1152 units

 

PRODUCT AND CODE: Ash Split Catheter with cuffs,   Batch/Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490, M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710,

M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660, M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310.

REASON: Catheter fails to remain anchored to patient.

MANUFACTURER/RECALLING FIRM: Medical Components, INC., Harleysville, PA.

DISTRIBUTION: Nationwide

QUANTITY: 43292

 

WEEK ENDING SEPTEMBER 8

 

PRODUCT AND CODE: Ventak Prism Automatic Implantable Cardioverter Defibrillators, VR Model 1850, VR HE Models 1852 and 1857, DR Model 1851, and DR HE Models 1853 and 1858.  Codes: Serial Numbers:

Ventak Prizm VR Model 1850: 103440-103442, 103447-103470, 103472-103473, 103475, 103479-103515, 103517-103847, 103849-103880, 103882-104235, 104237-104883, 104885- 104886, 104888, 104891-105008, 105010-105949, 105951-106009, 106012- 109299, 109301-109303, 109305-109845

Ventak Prizm DR Model 1851: 307946, 307972, 307976, 307988, 307995-308002, 308006-308007, 308009, 308011, 308016, 308019-308020, 308026-308028, 308030-308047, 308054, 308069-308075, 308077-308115, 308118-308146, 308148- 308155, 308158-308269, 308271-308285, 308288-308309, 308311-308320, 308322-308326, 308328-308388, 308390-308406, 388408-308431, 308433- 308434,308436-308437, 308439-308665, 308667-308699, 308701-308713, 308715-308747, 308749-308790, 308792-308825, 308827-388970, 308972-308989, 308991, 308993-309294, 309296-309509, 309511-309842, 309844-310083, 310085-310095, 310098-310101, 310104-310105, 310108-310111, 310128-310175, 310177-310222, 310224-310225, 310227-310248, 310251- 310307, 310309-310329, 310335-310337, 310341-310387, 310389-310409, 310411-310943, 310945-311423, 311425-312590, 312592-312815, 312817-313201, 313203-314612

Ventak Prizm VR HE Model 1852: 100000-100507

Ventak Prizm DR HE Model 1853: 300005-300011, 300013-300014, 300017, 300019-300020, 300022, 300031-300033, 300035, 300037-300038, 300045-300063, 300065-300066, 300068- 300150, 300152, 300154-300280, 300282-300286, 300288-300317. 300319-300324, 300326-301611

Ventak Prizm VR HE Model 1857: 500000-500123

Ventak Prizm DR HE Model 1858: 600000-600129

REASON: Devices could inappropriately go into Safety Mode limiting therapy.

MANUFACTURER/RECALLING FIRM: Guidant Corporation,  Cardiac Pacemakers,  St. Paul, MN.

DISTRIBUTION: Nationwide and World wide.

QUANTITY: 13,833 defibrillators

 

PRODUCT AND CODE: Infusion Pump.  Model PC-1, 220V CE, with software versions 8.12 and 8.13, Marked “International Only”.

REASON: The devices have the potential for a motor stall thereby affecting fluid delivery.

MANUFACTURER/RECALLING FIRM: Alaris Medical Systems, Inc., San Diego, CA.

DISTRIBUTION: Argentina, Australia, Chile, China, Hong Kong, Malaysia, Netherlands, New Zealand, Peru, Singapore, South Korea, United Kingdom.  Also, U.S. Defense Department under contracts V797P-4091A and SP0200-98-D-8002.

QUANTITY: 5820

 

PRODUCT AND CODE: Stryker Secure Med/Surg Bed, Model No. 3000-AC powered Hospital Bed; all units with serial numbers beginning with the first four digits 9505 through 9610.

REASON: The fasteners which hold the side rails can loosen over time and make the side rail unstable, which may allow a patient to fall out of bed.

MANUFACTURER/RECALLING FIRM: Stryker Corp., Kalamazoo, MI.

DISTRIBUTION: United States, Canada, Hong Kong, Mexico, Saudi Arabia, Ukraine, United Arab Emirates and the United Kingdom.

QUANTITY: 5442

 

PRODUCT AND CODE: Cryovale Allograft Heart Valve. CODE:  6193676

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: PA

QUANTITY: 1

 

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 3942406; Cryovalve Allograft Heart Valve, Model No. PV00, Serial No.3942392.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: CA and FL

QUANTITY: 2

 

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6064264; Cryovalve Allograft Heart Valve, Model No. PV00, Serial No. 6064272

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: NV and NM

QUANTITY: 2

 

PRODUCT AND CODE: Cryovalve Allograft Heart Valve; Model No.PV00, Serial No. 6197116.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: CO

QUANTITY: 1

 

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6105661. 

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: NV

QUANTITY: 1

 

PRODUCT AND CODE: Cryovalve Allograft Heart Valve;  Model No. AV00. Serial No.3988317.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: IL

QUANTITY: 1

 

PRODUCT AND CODE: Model SkinMaster System; CODE:  SkinMaster MD7 Skin Rejuvenation System and SkinMaster Beauty Pro 5 System.

REASON: The device failed to comply with 21 CFR 1040.11(a)(2) in that the units were introduced into commerce without safety labels and user information that comply with the Federal laser product performance standard, 21 CFR 1040.10 and 11.

MANUFACTURER/RECALLING FIRM: Sybaritic Inc./Symedex LLC, Minneapolis, MN

DISTRIBUTION: Nationwide.

QUANTITY: 150 SkinMaster MD7 Skin Rejuvenation System units and 50 SkinMaster Beauty Pro 5 System units

 

PRODUCT AND CODE: Gas machine for anesthesia. CODE:  4114586-001.

REASON: Reports of unintended PEEP greater than 20 cmH20, all occurring at same hospital.

MANUFACTURER/RECALLING FIRM: North American Drager, Telford, PA.

DISTRIBUTION: Nationwide and Canada.

QUANTITY: 464 units.

 

PRODUCT AND CODE: E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

CODES:   

a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above

b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above

c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed.

REASON: Incorrect orientation of acquired patient data

MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc. Hoffman Estates, IL.

DISTRIBUTION: Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands.

QUANTITY: 109 units.

 

PRODUCT AND CODE: Baxter Interlink and Regular I.V. Sets; sterile, nonpyrogenic fluid path.

CODES:

a) Product code 2C5487, lot R212308

b) Product code 2C5493, lot R212373

c) Product code 2C5531, lots R211250, R211359, R211383,R211466, R211581

d) Product code 2C5543, lot R211565

e) Product code 2C5593, lot R211128

f) Product code 2C5641, lot U572784R

g) Product code 2C6509, lot U571232R

h) Product code 2C6511, lots U570747R, U570838R

i) Product code 2C6519, lots R207191, R207266, R207357, R208678, R211334, R211417, R211599, R211623

j) Product code 2C6521, lot U569509R

k) Product code 2C6537, lots R207167, R207209, R207217, R207225, R207233, R207308, R207324, R207340, R207381, R207456, R207522, R207654, R207712, R207852, R207969, R208017, R208066, R208645, R208686, R208744, R208785, R208835, R208843, R208884, R208934, R208959, R208983, R209007, R209031, R209049, R209130, R209163, R209213, R209312, R209445, R209585, R209684, R211136, R211201, R211300, R211367, R211433, R211516, R211672, R211730, R211755, R211813, R211946, R211979, R212001, R212035, R212092, R212134, R212142, R212167, R212217, R212316, R212324, R212365, R212415

l) Product code 2C6546, lots R208769, R208868, R208975, R209056, R211052, R211102, R212126, R212209

m) Product code 2C6571, lots R209148, R209239, R209338, R209452, R211276

n) Product code 2C6593, lots U570135R, U570192R, U570085R

o) Product code 2C6606, lots R209023, R209072, R209080

p) Product code 2C6607, lots U569392R, U572156R

q) Product code 2C6612, lots R207183, R207258, R207290, R210104, R210146

r) Product code 2C6723, lot U570531R

s) Product code 2C6757, lots U569012R, U569228R, U569301R, U569863R, U570291R, U571828R, U571984R

t) Product code 2C6891, lots U571570R, U571752R, U571943R, U573295R

u) Product code 2C7542, lot U568303R

v) Product code 2C7560, lots U571588R, U572347R

w) Product code 2C7562, lots U568964R, U571364R, U571489R

x) Product code 2C7564, lots U570440R, U570499R, U571273R, U571554R, U571968R, U572420R, U572479R

y) Product code 2C7566, lots U570267R, U570317R, U571760R, U572511R

z) Product code 2C7591, lot U571745R

aa) Product code 2C7617, lots U568568R, U568873R, U572305R

bb) Product code 2C9903, lot U568576R

cc) Product code 2C9907, lot U569160R

dd) Product code 2H6519, lots R210047, R210179, R210211

ee) Product code 2N3378, lots U573063R, U573451R, U573634R, U574012R, U574178R

ff) Product code 2N9191, lot U568543R

gg) Product code 3C0059, lot U573030R

hh) Product code 4C7773, lot U568535R

ii) Product code 4C7774, lot U568428R

jj) Product code 4C7776, lot U569384R

REASON: Pinholes in protector cap of luer lock.

MANUFACTURER/RECALLING FIRM: Baxter Productos Medicos Ltd. Cartago, CR

RECALLED BY: Baxter Healthcare Corp. Round Lake, IL

DISTRIBUTION: Nationwide and Canada, New Zealand, Australia and Japan.

QUANTITY: 2,480,964 sets.

 

PRODUCT AND CODE: Abbott LCx Probe System Chlamydia trachomatis Assay Amplification & Detection Kit; an in-vitro diagnostic.

list 09B11 - U.S. labeling and list 07A91 - rest of world labeling

CODES:   list no.09B11 - U.S. labeling: lots 65731M300, 65738M300, 65739M300, 65740M300, 65741M300, 66518M100, 67421M100, 67956M200, 68579M200, 68580M200, 68581M200, 68744M200, 68748M200, 69246M100, 69403M100, 70681M200, 70683M200, 70685M200, 70686M200, 70687M200, 70688M200, 70689M200, 70784M300, 70785M300, 70786M300, 70787M300, 70788M300, 70790M300, 70793M300, 70983M300, 71040M200, 72249M200, 72264M200

list no. 07A91 - rest of world labeling: lots 65802M100, 66289M300, 66290M300, 67207M200, 67208M200, 67210M200, 67394M100, 67445M200, 68255M200, 68258M200, 69861M100, 69862M100, 70690M200, 70692M200, 70693M200, 70695M200, 70698M200, 70699M200, 72003M200, 72005M200, 72127M100, 72421M200, 72980M100

REASON: High negative control rates resulting in invalid runs and non-repeating positive.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park ,  IL

DISTRIBUTION: Nationwide and Brazil, Canada, Great Britain, Japan, Hong Kong, Taiwan, Austalia, and New Zealand.

QUANTITY: 37,957 kits.    

 

PRODUCT AND CODE: AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20; an In Vitro diagnostic assay for the quantitative determination of vitamin B12.  Codes:    list 3C79-20, lots 71097M100 and 71098M100

REASON: Calibration failures and nonreproducible results.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Canada, Australia, England, Hong Kong, New Zealand and Singapore.

QUANTITY: 1549 kits        

 

PRODUCT AND CODE: 7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set.

CODE: Catalog # MCTC730K, Lot #M029230

REASON:  Mislabeled - incorrect priming volume

MANUFACTURER: Medical Components, Inc., Harleysville, PA

DISTRIBUTION: Nationwide and Argentina, Italy, Canada, Netherlands, and United Kingdom.

QUANTITY: 91 trays

 

PRODUCT AND CODE: MEDCOMP BIO-FLEX CS CATHETER (CS100)

CODES: Catalong #BFL-6 - lots:  M813770, M819200, M820840, M902950, M903840, M907780, M915320M919550, M921320, M929930, M933270 and M936870.

Catalog #BFR-6CTT  (left side) - lots: M912540, M919140, M932310, and M934780.

Catalog #BFR-6CTT (right side) - lots: M912550, M915330, M919130, M924550, M932320,M935480, M937950.

Catalog #BFR-6 - lots:  M728810, M801970, M809360,M813780, M819050, M819980, M820830, M900800, M902960, M03830, M904290, M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450, M933260, M936500, M937960.

Catalog #BFR-70 - lot: M928700.

Catalog #BFS-6 - lot: M834100, M903280, M912650, M914740, M927830, and M928340.

Catalog #BFS-6CTT - lots:  M912560, M931380 and M932530.

Catalog #TRAY 452 - lots:  M912380, M916450, M919100, M924370, and M933050.

Catalog #TRAY 453 - lot: M912390.

REASON: Longitudinal slits

MANUFACTURER: Medical Components, Harleysville, PA

DISTRIBUTION: Hong Kong, Netherlands, Portugal, Hungary, Switzerland, Puerto Rico, united Kingdom, Sweden, and Thailand.

QUANTITY: 22876 catheters

 

PRODUCT AND CODE: Silicone catheters

CODE: All lots.

MANUFACTURER: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA

REASON:  Resent instructions for silicone catheters - not to use iodine

DISTRIBUTION: Nationwide, Austria and Guam.

QUANTITY: Unknown

 

PRODUCT AND CODE: Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software,  5.1

CODE: Version 5.1

MANUFACTURER: DADE BEHRING, INC., NEWARK, DE

REASON:  Incorrect low results for a number of patient samples.

DISTRIBUTION: Nationwide

QUANTITY: 1696 units

 

PRODUCT AND CODE: Pride Jazzy Scooter.

CODES: 1100, 1104, 1120, 1170 and PHC1.

REASON: Tire exploded

MANUFACTURER: PRIDE MOBILITY PRODUCTS CORP., EXETER, PA

DISTRIBUTION: Nationwide and England, Brazil, China, Belgium, Italy, Murcia, and Austrailia.

QUANTITY: 61510 units

 

PRODUCT AND CODE: Revo Scooter.

CODES: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow).

REASON:  Scooter drive system may engage while parking brake is inactive

MANUFACTURER/RECALLING FIRM: Shanghai Global Fabtech Plastic Products,  Shanghai, China, 

DISTRIBUTION: Nationwide and Liftgate, Ontario, Canada.

QUANTITY: 1152 units

 

PRODUCT AND CODE: Drager Vapor 2000 Sevoflurane Vaporizers

CODES: Catalog Number:  2000 Serial Numbers:  ARPH-0485, ARPH-0484, ARPH-0483, ARPH-0482, ARPH-0481, ARPH-0480, ARPH-0473, ARPH-0470, and ARPH-0469.

REASON: Mislabeled - Sevoflurane labeled as Isoflurane

MANUFACTURER: DRAGER MEDIZINTECHNIK GMBH LUEBECK, 

RECALLED BY: North American Drager Telford, PA

DISTRIBUTION: PA

QUANTITY: 3

 

PRODUCT AND CODE: Percutaneous Sheath Introducer Kit.

CODES: Catalog  #AK-09800, Lots:  RF0070524, RF0072194, RF0072195, RF0083177, RF0083178, RF0084453, RF0084454, RF0091533,  and RF0091534.

Catalog  #AK-09801, Lots:  RF0084462, RF0089390, and RF0080612.

Catalog #AK-09803, Lots:  RF0072212, RF0073195, and RF0084474.

Catalog #AK-09880, Lot:  RF0072232.

REASON: Valve may leak under certain conditions

MANUFACTURER: ARROW INTL., INC., READING, PA

DISTRIBUTION: Nationwide and Bangkok, Canada, Helsinki, Tokyo.

QUANTITY: 18170

 

PRODUCT AND CODE: Colleague Single Channel Volumetric Infusion Pumps, Codes:  Product code 2M8151, all serial numbers less than 10110001CS.

REASON: Battery related failures.

MANUFACTURER/RECALLING FIRM: Baxter Healthcare Corporation, Singapore, SN.

RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division,  Round Lake, IL

DISTRIBUTION: Nationwide to hospitals.

QUANTITY: 80,000 pumps

 

PRODUCT AND CODE: Disposable Scalpels labeled as sterile.

CODE:

Size 10 scalpels - Lot # 2410

Size 11 scalpels - Lot # 2412

Size 12 scalpels - Lot # 2293

Size 15 scalpels - Lot # 2428

Size 20 scalpels - Lot # 2399

REASON: Packaging defect (weld seals)/sterility may be compromised.

MANUFACTURER/RECALLED BY: ZNC International Inc., Port Chester, NY.

DISTRIBUTION: NY , PA , OH , FL, MI, NC, IL, TX, WI . 

QUANTITY: Lot # 2410: 87 boxes;  Lot # 2412: 400 boxes; Lot #2293: 100 boxes; Lot #2428: 500 boxes;  Lot #2399:  39 boxes.     

 

PRODUCT AND CODE: Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs. 

All products contain a label that states “SSIS Inc.  Date  **Lot # ** Hos Part # ** Part Description:  **  Product has been EO Gas terilized.***” CODE:  3527

REASON: Sterility may be compromised.

MANUFACTURER: Unknown

RECALLED BY: Surgical Instrument Service & Savings, Inc. Sisters, OR,

DISTRIBUTION: OR.

QUANTITY: 12 pkgs saw blades; 7 high speed burrs, 12 twist drill bits, 7 burrs    

               

PRODUCT AND CODE: Servo Ventilator, 300/300A

REASON: Failure of front panel potentiometers due to oxidation

MANUFACTURER: Siemens Elema AB Solna, 

DISTRIBUTION: Nationwide

QUANTITY: 5273

 

PRODUCT AND CODE: Agilent Technologies (formerly Hewlett Packard Co.)(A)Anesthesia Monitoring Systems, M1165A, M1166A,

M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262

(B)Upgrade kits M1160A and M1170A with option LO1 Anesthesia Monitoring Systems, Models: M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Released C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S

Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262 Upgrade kits M1160A and M1170A with option LO1

REASON: Monitoring and alarm functions maybe temporarily disabled

MANUFACTURER: AGILENT TECHNOLGIES (HEWLETT-PACKARD GMBH) BOEBLINGEN, BADEN-WTTBG,

RECALLED BY: Agilent Technologies, Inc., Andover, MA

DISTRIBUTION: Nationwide, VA Medical Centers in CA, MO, GU, 

QUANTITY: 8 devices; 152 kits

 

PRODUCT AND CODE: Ash Split Catheter with cuffs.

CODES:  Batch Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490,

M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710, M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660,

M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310.

REASON: Catheter fails to remain anchored to patient.

RECALLED BY: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA

DISTRIBUTION: Nationwide

QUANTITY: 43292

 

PRODUCT AND CODE: Animas R1000 Insulin Pump, 00-02688-01, 00-02864-01,00-02871-01, 00-02938-01, 00-02945-01, 01-02865-

01, 01-02872-01,01-02939-01, 02-02859-01, 02- 02866-01, 02-002873-01, 02-02880-01, 03-02698-01, 03-02867-01, 03-02874-01, 04-02868-01, 04-02875-01, 04-02882-01, 05-02869-01, 05-02876-01, 05-02883-01, 05-02890-01,06-02884-01, 07-02878-01, 07-02885-01, 07-02892-01, 09-02887-01,09-02894-01, 10-02888-01, 10-02895-01, 11-02889-01, 11-02896-01,12-02897-01, 13-02898-01, 14-02899-01, 47-03002-01, 48-03003-01, 48-03010-01, 49-03004-01, 49-03011-01, 50-03012-01, 50-03100-01, 51-03013-01, 51-03101-01, 52-03014-01, 52-03021-01, 52-03102-01, 53-03008-01, 53-03015-01, 53-03022-01, 53-03110-01, 54-03009-01, 54-03111-01, 55-03017-01, 55-03024-01, 55-03105-01, 55-03112-01, 55-03200-01, 56-03018-01, 56-03025-01, 56-03032-01, 56-03106-01, 56-03113-01, 56-03120-01, 57-03026-01, 57-03033-01, 57-03040-01, 7-03114-01, 57-03121-01, 58-03027-01, 58-03034-01, 58-03108-01, 59-03028-01, 59-03035-01, 59-03042-01, 59-03116-01, 59-03123-01, 59-03130-01, 59-03204-01, 60-03036-01, 60-03043-01, 60-03050-01, 60-

03117-01, 60-03131-01, 61-03037-01, 61-03044-01, 61-03118-01, 61-03125-01, 62-03038-01, 62-03045-01, 62-03052-01, 62-03119-01, 62-03133-01, 63-

03039-01, 63-03046-01, 63-03053-01, 63-03127-01, 63-03134-01, 63-03141-01, 64-03047-01, 64-03054-01, 64-03128-01, 64-03135-01, 65-03048-01, 65-

03055-01, 65-03062-01, 65-03129-01, 65-03150-01, 66-03049-01, 66-03056-01, 66-03070-01, 66-03144-01, 67-03064-01, 67-03071-01, 67-03138-01, 68-

03058-01, 68-03072-01, 68-03139-01, 68-03146-01, 69-03059-01, 69-03066-01, 69-03073-01, 69-03080-01, 69-03147-01, 69-03154-01, 70-03037-01, 70-

03074-01, 70-03081-01, 71-03068-01, 71-03082-01, 71-03149-01, 72-03069-01, 72-03083-01, 73-03077-01, 73-03091-01, 73-03158-01, 73-03165-01, 74-

03078-01, 74-03085-01, 74-03092-01, 75-03079-01, 75-03086-01, 75-03093-01, 76-02710-01, 76-03087-01, 76-03094-01, 77-02528-01, 77-03088-01, 78-

02617-01, 78-02712-01, 78-03089-01, 78-03184-01, 79-02706-01, 79-02720-01, 79-02801-01, 79-03097-01, 80-02640-01, 80-03098-01, 80-03193-01, 81-

02708-01, 81-02722-01, 81-03099-01, 81-03187-01, 83-02629-01, 83-02900-01, 84-02651-01, 84-02718-01, 84-02901-01, 85-02733-01, 85-02902-01, 86-

02639-01, 86-02808-01, 86-02815-01, 86-02822-01, 86-02903-01, 86-02910-01, 87-02647-01, 87-02830-01, 87-02904-01, 87-02911-01, 88-02493-01, 88-

02736-01, 88-02824-01, 88-02905-01, 88-02912-01, 89-02670-01, 89-02744-01, 89-02751-01, 89-02906-01, 89-02913-01, 89-02920-01, 90-02488-01, 90-

02745-01, 90-02819-01, 90-02907-01, 90-02914-01, 91-02908-01, 91-02915-01, 91-02922-01, 92-02673-01, 92-02828-01, 92-02842-01, 92-02909-01, 92-

02916-01, 92-02923-01, 92-02930-01, 93-02667-01, 93-02917-01, 93-02924-01, 93-02931-01, 94-02851-01, 94-02918-01, 94-02925-01, 94-02932-01, 95-

02852-01, 95-02919-01, 95-02926-01, 95-02940-01, 96-02589-01, 96-02691-01, 96-02765-01, 96-02846-01, 96-02927-01, 96-02934-01, 96-02491-01, 97-

02692-01, 97-02854-01, 97-02861-01, 97-02928-01, 97-02942-01, 98-02686-01, 98-02767-01, 98-02848-01, 98-02862-01, 98-02943-01, 99-02863-01, 99-

08270-01, 99-02937-01, and 99-02944-01.

REASON: Infusion pumps may have defective vents causing unintentional dose of insulin

MANUFACTURER: Animas Corporation, Frazer, PA

DISTRIBUTION: Nationwide

QUANTITY: 239 units

                               

PRODUCT AND CODE: OncoSeed Iodine 125 Seeds; a welded titanium capsule containing Iodine-125 absorbed onto a silver rod.

CODE:  Model 6711, lot E9448C.

REASON: Mislabeled seeds.

MANUFACTURER/RECALLING FIRM: Medi-Physics, Inc. dba Nycomed Amersham Imaging, Arlington Heights, IL.

DISTRIBUTION: AL.

QUANTITY: 110 seeds.

 

PRODUCT AND CODE: A.T.S. Reusable Tourniquet Cuffs, Velcro Component, Part No. 650199, Lot Nos. 92299500, 92308600, 92313500,

92313600, 92313700, 92322200, 92322300, 92322400, 92322500, 92322600, 92322700, 92323000, 92323100, 92327600, 92328000, 92328100, 92328200, 92328500, 92328600;

REASON: The Velcro hook fastener component tore during use.  Internal tensile strength testing showed that the Velcro component had approximately half of the tensile strength of a normal product.

MANUFACTURER/RECALLING FIRM: Zimmer, Inc., Statesville, NC.

DISTRIBUTION: Nationwide and to Spain, Germany, France, Belgium, England, Denmark, Italy, Finland, Singapore, Latin America, Israel, Middle East, Canada, Australia, Japan and Korea.

QUANTITY: 3124

 

PRODUCT AND CODE: PRESS MATE Advantage Vital Sign Monitor. Models 9861, 9871

CODE: Serial Numbers 310004 through 311135

REASON: The monitor may display erratic respiration rates and cause a false or no alarm.

MANUFACTURER/RECALLING FIRM: COLIN CORP. Komaki City, Japan

RECALLED BY: Colin Medical Instruments Corp., San Antonio, TX

DISTRIBUTION: Nationwide

QUANTITY: 963

 

PRODUCT AND CODE: Vitros Clinical Chemistry Cholesterol (CHOL) Slides, Coating 0309, Catalog No. 1669829,

Lot Numbers: 0823-0309-7912 0823-0309-8001 0823-0309-8002 0823-0309-8069 0823-0309-8070 0823-0309-8071 0823-0309-8108 0823-0309-8109 0823-0309-8232 0823-0309-8233 0823-0309-8234 0823-0309-8236 0823-0309-8243 0823-0309-8244 0823-0309-8343 0823-0309-8344 0823-0309-8345 0823-0309-8378 0823-0309-8379 0823-0309-8445 0823-0309-8446 0823-0309-8447 0823-0309-8457 0823-0309-8552 0823-0309-8553 0823-0309-8614 0823-0309-8615 0823-0309-8627 0823-0309-8628 0823-0309-8629 0823-0309-8672 0823-0309-8673 0823-0309-8675 0823-0309-8676 0823-0309-8677 0823-0309-8702 0823-0309-8703 0823-0309-8704 0823-0309-8762 0823-0309-8763

REASON: The use of the referenced product may result in positively biased results at high concentrations.

MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

DISTRIBUTION: Nationwide and Australia, Canada, France, Germany, India, Italy, Portugal, Singapore and the UK

QUANTITY: 12,620 packs-domestic; and 8,603 packs-international

 

PRODUCT AND CODE: Vitros Clinical Chemistry Specialty Diluent,Catalog No. 8559825, Lot No. Y1844.

REASON: Product is labeled with the incorrect expiration date of 31 May 2003.  The correct expiration date is 31 May 2002.

MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

DISTRIBUTION: CA, FL, KS, MA, NY, OK, PA, SD, TX, VT, and WI. Product was shipped to three government facilites under contract #V797P-6565A. 1) Ellsworth AFB, SD 2) Walter Reed Army Med. Ctr., Washington, DC 3) Columbus AFB, Columbus, MS

QUANTITY: 48 boxes

 

PRODUCT AND CODE: Plastic Material (Buttons) used to make Rigid Gas Permeable Contact Lenses: Boston II (oprifocon A) Green.

Product No.1000-A, Lot No. 00264PTC001, Rigid Gas Permeable Lens for Daily Wear; Boston Equalens II (itafocon A) Green wit UV, Product No. 1500-A, Lot Nos. 00214PTC003, 99279PTC004, 99279PTC005, 99279PTC006, Rigid Gas Permeable Contact Lenses for Daily Wear or Extended Wear; Boston ES (enflufocon A) Green with UV, Product No. 2200-A, Lot Nos. 00236PTC001, 00264PTC002, Rigid Gas Permeable

Contact Lenses; Boston ES (enflufocon A) Gray with UV, Product No. 2200-G, Lot No. 00236PTC002, Rigid Gas Permeable Contact

Lenses; Boston XO (hexafocon A) Green with UV, Product No. 2300-A, Lot Nos. 00040PTC013, 00040PTC014, 00040PTC015, 00165PTC008, 00278PTC006, Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lenses for Daily Wear; Boston EO (enflufocon B) Green with UV, Product No. 2600-A, Lot Nos. 00222PTC006, 00313PTC002, Rigid Gas Permeable Contact Lenses.

REASON: The contact lenses contained D&C Yellow No. 11which is not approved for contact lens use.

MANUFACTURER/RECALLING FIRM: Polymer Technology (A Bausch & Lomb, Inc. Co.) Rochester, NY.

DISTRIBUTION: Nationwide and worldwide.

QUANTITY: 92,455 units

 

PRODUCT AND CODE: Behring Coagulation System (BCS) software version 2.2.  CODES:  Model OVIO03 Version 2.2

REASON: Leak of piston pump valve introduces air bubbles.

MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg

RECALLED BY: Dade Behring, INC., Newark, DE

DISTRIBUTION: NY, IL and MI.

QUANTITY: 3 units.

 

PRODUCT AND CODE: Five Dimension RxL Flex Reagent Cartridges. The product is composed of 1) Ferritin (FERR), 2) Human Chorionic

Gonadotropin (HCG), 3) Mass Creatine Kinase MB Isoenzyme (MMB), 4) Myoglobin, and 5) Prostate Specific Antigen (PSA).  FERR has 120

tests/carton; 30 tests/cartridge.  HCG has 120 tests/carton; 30 tests/cartridge.  MMB has 160 tests/carton; 40 tests/cartridge.  MYO has 120 tests/carton; 30 tests/cartridge.  PAS has 120 tests/carton; 30 tests/cartridge.  The product is sold by the cartridge or 4 cartridges per carton.

CODES:  FERR Lot FR9351 exp. 12/17/99, FERR Lot IR0063 exp. 3/3/99, HCG Lot HP0177 exp. 6/25/00, MMB Lot FP0100 exp. 4/9/00, MMB Lot HN0178 exp. 6/26/00, MMB WA0190 exp. 7/8/00, MYO Lot FP0074 exp. 3/14/00, MYO Lot FN0074 exp. 3/14/00, PSA Lot WA0253 exp. 9/9/00, and PSA Lot HP0239 exp. 8/26/00.

REASON: Decline in stability following hydration.

MANUFACTURER/RECALLING FIRM: Dade Behring, Inc., Newark, DE.

DISTRIBUTION: Nationwide and Germany, Australia, Canada, and Belgium.

QUANTITY: 6447.

 

PRODUCT AND CODE: Canon CXDI-22 X-Ray Digital Radiography System; CODE: Serial Numbers: 200001 through 200037 (except 200036).

REASON: The exposure function may fail due to a blown fuse.

MANUFACTURER/RECALLING FIRM: Canon U.S.A., Inc., Lake Success, NY.

DISTRIBUTION: NJ, NY, NC, OH, FL, WA, CA, TX, HI.

QUANTITY: 27

 

PRODUCT AND CODE: IMMULITE 2000 Antithyroid peroxidase (Anti TPO) kit, Catalog Number L2KTO2 121.

CODE:  Immulite 2000 Antithyroid Peroxidase (TPO), kit lot L2KT02 121.

REASON: Component mix-up. Wrong bead lot.

MANUFACTURER/RECALLING FIRM: Euro DPC United Kingdom.

RECALLED BY: Diagnostic Products Corp., Los Angeles, CA

DISTRIBUTION: AZ, CA, NY, NJ, OR, MI, NM, MO, Korea and Japan.

QUANTITY: 55.

 

PRODUCT AND CODE: MicroBioLogics Streptococcus bovis, Derivative of ATCC# 49147, Catalog Numbers 0631V, 0631S, and 0631P. 

This product was packaged into 3 packaging configurations under the MicroBioLogics brand name:

1.  Catalog number 0631V - A single vial that contains 10 individual LYFO-Disk pellets streptococcus bovis.

2.  Catalog number 0631S - A canster with 10 individual KWIK-STIK units of streptococcus bovis.

3.  Catalog number 0631P - A wrapped set that contains 2 individual KWIK-STIK units of streptococcus bovis.

Packaging configurations 2 and 3 are labeled for a private label distributor, PML Microbiologicals, Wilsonville, OR.  That name and address appears at the top of the label, with the product identification below.

Recalled product in a fourth packaging configuration was made and labeled for HealthLink.  It is individually-wrapped Kwik-Stik labeled

“HealthLink*** Cat # HL3480 (49147) S. bovis”.  HealthLink is located in Jacksonville, FL.  CODE:  Lot numbers 63131 and 63132.

REASON:  The product contains the wrong bacteria strain.

MANUFACTURER/RECALLING FIRM: MicroBioLogics, Inc., St. Cloud, MN.

DISTRIBUTION: Nationwide, Canada and South Africa.

QUANTITY: 462 bacteria pellets, packaged 1-10 per package.

 

PRODUCT AND CODE: EasyBlood Gas Analyzer.

CODES:  EasyBlood Gas Analyzers with Software version below M4.20.

REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg.

MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA.

DISTRIBUTION: Malaysia, Russia, Hong Kong, Switzerland, Argentina, Czech Republic, Canada, Hungary, Chile Finland, Turkey, Italy, South Africa, Korea, Pakistan, Greece, Portugal, Mexico, Venezuela, Philippines, Bangladesh.

QUANTITY: 229.

 

PRODUCT AND CODE: Vaxcel 5F SL PICC(Peripherally Inserted Central Cannula), Clampable Hub Catalog #45-443, Lot Number 005827

Codes:   Vaxcel 5F SL PICC (Peripherally Inserted Central Cannula), Clampable Hub, 60 cm Wire Catalog #45-443, Lot Number 005827.

REASON: Product may not have a clampable hub.

MANUFACTURER/RECALLING FIRM: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT.

RECALLED BY: MEDI TECH, a division of Boston Scientific Corp. Watertown, MA

DISTRIBUTION: Nationwide to Medical Centers.

QUANTITY: 699.

 

PRODUCT AND CODE: Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003;

Wako Lyophilized Chemistry 1, Product Code 1104A, Lot Number 7704A01, MFD Mar-00, Exp Date 31 Mar 2003

REASON: Unit recalled by component manufacturer due to positive for anti-HCV

MANUFACTURER/RECALLING FIRM: Bio-Rad Laboratories, Inc. Irvine, CA.

DISTRIBUTION: Japan.

QUANTITY: Unknown.

 

PRODUCT AND CODE: Bard InLay Ureteral Stent, 4.7 Fr. Diameter.CODES:  Catalog Number 777424 - Lot Number 07BK2302

        Catalog Number 777426 - Lot Number 07GK0081.

REASON: Packaged with wrong guidewire.

MANUFACTURER/RECALLING FIRM: Bard Glens Falls Operation, Queensbury, NY.

RECALLED BY: C. R. Bard, Inc. Covington, GA

DISTRIBUTION: Nationwide.

QUANTITY: 150 Units.

 

PRODUCT AND CODE: Diamedix/immunosimplicity brand of anti-Sm/RNP Enzyme Immunoassay Test Kit, For in Vitro Diagnostic Use, 96 test kit, catalog No. 720-270.

CODES:  50700Z, Expiration date of April 2001.  

REASON: Positive control failed to recover within its assigned range.

MANUFACTURER/RECALLING FIRM: Diamedix Corp, Miami, FL.

DISTRIBUTION: NY and IL.

QUANTITY: 13.

 

PRODUCT AND CODE: Sunsoft Additions contact lenses, Sunsoft Multiples Toric, and Sunsoft Sphere Multiples.

CODES:  Various lot numbers and sequences.

REASON: Contact lenses may vary from the labeled power by as much as 0.75 diopters.

MANUFACTURER/RECALLING FIRM: Sunsoft Corp., Albuquerque, NM.

DISTRIBUTION: Nationwide and Canada, Denmark, France, Germany, Netherlands, Norway, Portugal, Sweden, and Turkey.

QUANTITY: 892 lenses.

 

PRODUCT AND CODE: Premier Human Lyme EIA, an in-vitro diagnostic test kit.  The kits should contain 2 microplates containing

96 test wells per plate.  Kits are packaged and sold individually.

CODES:  Lot #696032.018.

REASON: The kits are packaged with less test wells than labeled.

MANUFACTURER/RECALLING FIRM: Meridian BioScience, Inc., Cincinnati, OH.

DISTRIBUTION: CT, IA, MD, MA, NJ, VA, and Belgium.

QUANTITY: 151 kits.

 

PRODUCT AND CODE: Premier EBV IgG ELISA, in-vitro diagnostic test kits, packaged under the Gull label.

CODES:  Catalog Number:  EBE100.

REASON: Microwells that are washed automatically may result in an invalid test assay.

MANUFACTURER/RECALLING FIRM: Meridian Diagnostics, Inc., Cincinnati, OH.

DISTRIBUTION: Nationwide.

QUANTITY: 946 kits.

 

PRODUCT AND CODE: MRO Reverse Osmosis (RO) Water Treatment System.

CODE:  All MRO Hemodialysis RO Water Treatment Systems.

REASON: Defective sensor will result in a false high conductivity reading and trigger alarm.

MANUFACTURER/RECALLING FIRM: Ameriwater, Dayton, OH.

DISTRIBUTION: NY.

QUANTITY: 59 units.

 

WEEK ENDING SEPTEMBER 15

 

PRODUCT AND CODE: Sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw

Driver***Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***”.

Non-sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw Driver***Non-

Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***”.

Labeling for the product is labeled in part, “Instructions For Use***MacroPore Craniomaxillofacial (CMF) and Neurological (Neuro)

Surgery Products***DESCRIPTION***INDICATIONS*** CONTRAINDICATIONS***WARNINGS AND PRECAUTIONS***STORAGE AND HANDLING***POSSIBLE ADVERSE EFFECTS***PROCEDURE***CLEANING AND STERILIZATION*** CAUTIONS***MACROPORE***San Diego, CA 92121***”.CODES:     Lot 50489, Exp Date 5/2005

REASON: False perception of sterility on part of users.

MANUFACTURER/RECALLING FIRM: MACROPORE, INC. SAN DIEGO, CA

DISTRIBUTION: TN

QUANTITY: 62

 

PRODUCT AND CODE: Laser Product/Custom Gaging System; Model name and number:  Custom gaging system.

REASON: The products did not comply with the warning logotype, aperture label, identification and certification label requirements.

MANUFACTURER/RECALLING FIRM: Kurt Manufacturing Company, Minneapolis, MN

DISTRIBUTION: Nationwide

QUANTITY: 5 units

 

PRODUCT AND CODE: Dynarad Model HF-110A Mobile X-Ray System; Codes:  Model HF-110A, serial numbers 0101 through 1085

REASON: Cracks may occur in the yoke supporting the generator

MANUFACTURER/RECALLING FIRM: Dynarad Corp., Deer Park, NY.

RECALLED BY: Del Medical Imaging Corp., Franklin Park, IL

DISTRIBUTION: Nationwide, and International.

QUANTITY: 662 units

 

PRODUCT AND CODE: Multi-Therapy Ambulatory Infusion Pumps sold under the following labels:

a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump), 606000-40I (International),

606000-41 (Spanish), 606000-42 (Portugal), 606000-43 (France), 606000-44 (JMS), 606000-45 (Sweden), 606000-46 (Dutch) and 606000-47

(German)

b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832

CODES:    All serial numbers with installed software V2.06.5 and lower, or V2.10.3 and lower (International version).

REASON: The infusion pump may overinfuse in the PCA mode of operation.

MANUFACTURER/RECALLING FIRM: Sabratek Corp. Skokie, IL.

RECALLED BY: Baxter Healthcare Corp

DISTRIBUTION: Nationwide and International

QUANTITY: 2000 – 4000 pumps

 

PRODUCT AND CODE: Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R (refurbished); for continuous or intermittent fluid delivery through clinically acceptable routes of administration such as intravenous, intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications; Made in SingaporeCodes:  Product code 2M8151 and 2M8151R (refurbished), all units. 

REASON: Damaged power cord may result in arcing and potential burning

MANUFACTURER/RECALLING FIRM: Baxter Healthcare PTE Ltd. Singapore, SN

RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division Round Lake, IL

DISTRIBUTION: Nationwide

QUANTITY: 80,000 pumps

 

PRODUCT AND CODE: Medela BiliBed Phototherapy Lamp, Model 0383009; used for the treatment of newborns with neonatal jaundice (hyperbilirubinemia); Codes:Models 0383009, all serial numbers included in the ranges of 970933 through 972184 and 1000569 through 1004473

REASON: Failure of the internal housing fan allows temperature to rise around infant.

MANUFACTURER/RECALLING FIRM: Medela A.G. CH-6340 Baar, SZ

RECALLED BY: Medela, Inc. McHenry, IL

DISTRIBUTION: Nationwide, Canada and Mexico.

QUANTITY: 575 lamps

 

PRODUCT AND CODE: FreshLook (phemfilcon A) Toric for Astigmatism Soft Contact Lenses with Handling Tint;  the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box.  Codes: Lot 127945, expiration 2003-08

REASON: Mislabeled for corrective power, cylinder & axis

MANUFACTURER/RECALLING FIRM: Wesley Jessen Corporation, Des Plaines, IL

DISTRIBUTION: Nationwide, Canada, Australia and England.

QUANTITY: 119  6-packs

 

PRODUCT AND CODE: ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera

Systems to conduct cardiac Tomo and SPECT applications; 60195-5203.  Codes: All E.CAM gamma cameras with the Profile option with

ICON-P workstations and ICON software revision 8.1 or greater

REASON: Artifacts on images from profile scans

MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL

DISTRIBUTION: National and International

QUANTITY: 125 units

 

PRODUCT AND CODE: Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic

renal failure; 12 units per case; marketed under the following brand names:

a) Mera Meltra Nova 110 Hemodialyzer Cellulose Diacetate-N Membrane, cat. #277-451G

b) Altra Nova 170 Cellulose Acetate-N Hemodialyzer, cat. #201-472

c) Altra Nova 200 Cellulose Acetate-N Hemodialyzer, cat. #211-484G

Manufactured by Althin Medical AB, 37221 Ronneby, Sweden

d) Althin A-15 Althane Capillary Dialyzer, cat. #237-015Codes: Meltra Nova Model 110, product code 277-451G, lot 451-980911C

Altra Nova Model 170, product code 201-472, lots 472-980825A, 472-980923E, 472-981113B Model 200, product code 211-484G, lots 484-981009A, 484-981009C, 484-981012B, 484-990224B, 484-990311A, 484-990318C A Series Althane Model 1.5, product code 237-015, lots 1998M02R, 1998M02R1, 1998M02Z

REASON: Iritis patient reactions

MANUFACTURER/RECALLING FIRM: Manufactured by Althin Medical, Inc., Miami Lakes, FL

RECALLED BY: Baxter Healthcare Corp. Round Lake, IL

DISTRIBUTION: Nationwide and International.

QUANTITY: 37,901

 

PRODUCT AND CODE: E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

Codes: a) E.CAM Dual Head Variable System Gantry part #4280221, serial #0005 to 1215    5242826, serial #1001 to 3079

b) E.CAM Single Head Camera Gantry part #4380213, serial #0001 to 3023

REASON: Potential loss of engagement in radial drives.

MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL

DISTRIBUTION: Nationwide, and International.

QUANTITY: 541 units

 

PRODUCT AND CODE: RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes:  RadWorks Software Version 5.1 with Software Patch 5 or 7 and RadWorks Webviewer Software 5.1 running on RadWorks 5.1 Software Patch 5 or 7

REASON: Software anomaly causes image to be associated with wrong DICOM header

MANUFACTURER/RECALLING FIRM: Applicare Medical Imaging, B.V. ZEIST, 

RECALLED BY: GE Medical Systems Information Technologies, Mt. Prospect, IL

DISTRIBUTION: Nationwide through nine distributors in New Jersey, Wisconsin, Nebraska, Texas, Illinois, Colorado and Ohio.

QUANTITY: 3319 RadWorks 5.1 and 56 RadWorks WebViewer 5.1 licenses

 

PRODUCT AND CODE: Raven Prospore2 Biological Indicator Intended for Steam Sterilization (121 degrees C) Contains Bacillus stearothermophilus spores, packaged 50 tests per box; and Raven Prospore ii Biological Indicators (same product) packaged 10-

tests per box.  (NOTE: The label for the 10-test boxes is an old label which was in use for this lot.). CODE:  Lot No. 455, exp. 9/2002

REASON: Inappropriate color change.

MANUFACTURER/RECALLING FIRM: Raven Biological Laboratories, Inc. Omaha, NE

DISTRIBUTION: CA, FL, TX, NJ, TN, MD, MI and France, Germany, Turkey, Sweden, Italy, Brazil, Japan, Argentina, Croatia, Peru,

Spain, and the Netherlands.

QUANTITY: 615/50-pack boxes and 40/10-pack boxes.

 

PRODUCT AND CODE: VDRL Test Control Serum Set, Catalog No. 235201, Lot Nos. 149027LA and 149484LA;

REASON: The VDRL Weakly Reactive Serum Control demonstrates reactivity comparable to or stronger than the VDRL

Reactive Control Serum. The unexpected reactivity of the control invalidates the assay and the users cannot qualify the antigen present in the sample.

MANUFACTURER/RECALLING FIRM: Becton Dickinson Microbiology Systems, Sparks, MD.

DISTRIBUTION: Nationwide, PRR, Singapore, Thailand, Korea, India, Paraguay, Belgium and firm affiliates.

QUANTITY: 1374 sets

 

PRODUCT AND CODE: Ash Split Catheter, Bio-Flex Continuous/CAVH, Duo-Flow XTP, Hemo-Cath, Soft Line, and Tesio Hemodialysis and Apheresis Catheters.  These products are hemodialysis catheters; the three types affected are: long term (chronic), short term (acute) and femoral (hemofiltration) catheters.

Codes:    Long Term Catheters:

Ash Split Cath Long Term Hemodialysis Catheter (10FR x 18CM) - catalog number ASPC18P - all lots;

Ash Split Cath Long Term Hemodialysis Catheter (10FR x 24CM) - catalog number ASPC24P - all lots;

Bio-Flex Tesio Long Term Hemodialysis Catheter (7FR) - catalog number PBF - all lots; Tesio Long Term Hemodialysis Catheter (7FR) - catalog number MCTC730K - all lots;

Hemo-Cath Long Term Silicone Double Lumen Hemodialysis Catheter (8FR x 18CM) - catalog numbers SL18P and MCDLTSL18P - all lots; and Hemo-Cath

Long Term Silicone Double Lumen Hemodialysis Catheter (8FR x 24CM) - catalog numbers SL24P and MCDLTSL24P - all lots.

Short Term Catheters: Duo-Flow XTP Short Term Double Lumen Hemodialysis Catheter (9FR x 12CM) - catalog numbers XTP94CT and XTP94MT - all lots; Duo-Flow

XTP Short Term Double Lumen Hemodialysis Catheter (9FR x 15CM) - catalog numbers XTP96CT and XTP96MT - all lots; Hemo-Cath

Short Term Silicone Double Lumen Hemodialysis Catheter (8FR x 12CM) - catalog number SL12P - all lots; Soft-Line Short Term Double Lumen Hemodialysis Catheter (7FR x 10CM) - catalog number T74M - all lots;

Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 12CM) - catalog numbers T94C and T94M - all lots;

Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 15CM) - catalog numbers T96C and T96M - all lots; and

Soft-Line Short Term Double Lumen Hemodialysis Catheter (9FR x 20CM) - catalog numbers T98C and T98M - all lots.

Femoral Catheter: Continuous/CAVH Hemodialysi Catheter (5FR x 7.6CM) - catalog number MC5CAVH3 - all lots.

REASON: Unapproved for pediatric use as stated in literature.

MANUFACTURER/RECALLING FIRM: Medical Components, Inc., Harleysville, PA.

DISTRIBUTION: Nationwide, and Canada.

QUANTITY: Unknown

 

PRODUCT AND CODE: IVAC MedSystem III Infusion Pump:

Model No. 2860 (110V);

Model No. 2863 (110V);

Model No. 2865 (220V);

Model No. 2866 (220V);

MiniMed MMT 9500 (110V).

REASON: The motor drive is subject to premature wear which can cause alarms and error notices which may affect fluid delivery.

MANUFACTURER/RECALLING FIRM: Alaris Medical Systems, Inc., San Diego, CA

DISTRIBUTION: Nationwide and  International.

QUANTITY: Undetermined.

 

PRODUCT AND CODE: Touch-Proof Leadwires, Black and Red Wire, Micro-Z Neuromuscular Stimulators:

Black Wire, Part No. 0-24-ML WBLK-0-0, Lot No. 99H007

Red Wire, Part No. 0-24-ML WRED-0-0, Lot No. 99H008.

REASON: A design flaw (untapered pins) may cause an intermittent failure to conduct electrical energy from the stimulator to the electrode.

MANUFACTURER/RECALLING FIRM: Prizm Medical, Inc., Duluth, GA

DISTRIBUTION: Nationwide & Israel & Chennal.

QUANTITY: 214

 

PRODUCT AND CODE: Behring Coagulation System (BCS) software CODES:  Model OVIO03, Version 2.2

REASON: Leak of piston pump valve introduces air bubbles.

MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg

RECALLED BY: Dade Behring, Inc., Newark, DE

DISTRIBUTION: NY, IL,and MI

QUANTITY: 3 units

 

PRODUCT AND CODE: Dimension RxL integrated chemistry system.  Prostate Specific Antigen (PSA) Flex Reagent Cartridge.

Codes: catalog number RF450.

Lots: JS1284 exp. 10/11/01, IP1265 exp. 9/22/01,

IR1265 exp. 9/22/01, HN1240 8/28/01, UA1207 exp. 7/26/01,

UB1194 exp. 7/13/01, TC1174 exp. 6/23/01, FN1156 exp. 6/5/01,

SA1125 exp. 5/5/01, DP1102 exp. 4/12/01, PC1087 exp. 3/28/01,

CP1068 exp. 3/9/01, BM1045 exp. 2/14/01, AR1010 exp. 1/10/01,

LS0344 exp. 12/9/00, and KM0327 exp. 11/22/00.

REASON: False positive results - increased number.

MANUFACTURER/RECALLING FIRM: Dade Behring, Inc., Newark, DE.

DISTRIBUTION: Nationwide and to the following foreign countries: Venezuela, Denmark, Brazil, Austrailia, Guam, Canada,

Hong Kong, Belgium, and China.

QUANTITY: 10, 327 cartons

 

PRODUCT AND CODE: Medex Bifurcated Set, with SmartSite Valve, 25 sets per case.

Codes: Lot Number:  31A2255849, Cat Number:  MX20498

REASON: The device is labeled as Latex Free, however it actually contains latex.

MANUFACTURER/RECALLING FIRM: Medex, Inc. Hilliard, OH

RECALLED BY: Medex, Inc. Dublin, OH

DISTRIBUTION: MI

QUANTITY: 9 cases (225 sets)        

 

PRODUCT AND CODE: FlexiLab Laboratory Information System, Versions 5.23 and 5.3 with Microbiology Module.

REASON: Incorrect printing of lab test results.

MANUFACTURER/RECALLING FIRM: Sunquest Information Systens, Inc. Tucson, AZ

DISTRIBUTION: Nationwide and Denmark.

QUANTITY: Undetemined

 

PRODUCT AND CODE: FlexiLab Codes: v. 5.23 and 5.3    

REASON: Incorrect data is filed to patient file.

MANUFACTURER/RECALLING FIRM: Sunquest Information Systems, Inc. Tucson, AZ

DISTRIBUTION: Nationwide and United Kingdom, and Denmark.

QUANTITY: Undetermined

 

PRODUCT AND CODE: VidaMed Transurethral Needle Ablation (TUNA) System VTS PROVu ground pad Model Number(s): 7002

CODES: 510283; 515179; 519471; 520314

REASON: Potential burn of a return electrode following a TUNA procedure.

MANUFACTURER/RECALLING FIRM: Vidamed, Inc. Fremont, CA

DISTRIBUTION: Nationwide and International

QUANTITY: 8,037 units

 

PRODUCT AND CODE: FluidSense FS-01 Infusion PumpCodes:  Serial Numbers: 100302-102393 (not inclusive)

REASON: Keyboard may malfunction with stuck keys or provide no response to touch

MANUFACTURER/RECALLING FIRM: Mack Technologies, Westford, MA

RECALLED BY: Fluidsense Corp. Newburyport, MA

DISTRIBUTION: CA, FL, TN

QUANTITY: 1109

 

PRODUCT AND CODE: Precision PCx Blood Glucose Test Strips Codes: P/N 98757-01, Lot Number: 118545

REASON: Assigned High and Normal Control Ranges are incorrect

MANUFACTURER/RECALLING FIRM: MEDISENSE UK LIMITED ABINGDON,

RECALLED BY: Abbott Laboratories, Inc. Bedford, MA

DISTRIBUTION: Nationwide

QUANTITY: 3226

 

PRODUCT AND CODE: GEM Premier 5300; GEM Premier Plus 5500

Codes:  

a) GEM Premier Model No. 5300. All serial numbers

b) GEM Premier Plus Model 5500. All serial numbers

REASON: Inaccurate pO2 reading

MANUFACTURER/RECALLING FIRM: Instrumentation Laboratory Co. Ann Arbor, MI

RECALLED BY: Instrumentation Laboratory Co. Lexington, MA

DISTRIBUTION: Nationwide

QUANTITY: Model 5300: 400 units  Model 5500: 222 units        

 

PRODUCT AND CODE: Symmetra I-125 Brachytherapy Sources Sealed source, Radionuclide

Codes:  Symmetra I-125 Brachytherapy Sources

Lot #                       Labeled Activity Range      Actual Activity Range

B7012201033         .220 - .238 mCi                       .239 - .258 mCi Implanted

B701240103           .220 - .238 mCi                       .124 - .135 mCi Returned

B7010301026         .305 - .330 mCi                       .259 - .280 mCi Implanted

B712200001           .305 - .330 mCi                       .331 - .388 mCi Implanted

B712210001           .305-  .330 mCi                       .331 - .358 mCi Implanted

B712220001           .305 - .330 mCi                       .259 - .280 mCi Implanted

B712290001           .305 - .330 mCi                       .259 - .280 mCi Implanted

B701230102           .331 - .358 mCi                       .281 - .304 mCi Returned

B712190001           .331 - .358 mCi                       .359 - .388 mCi Implanted

B712110003           .359 - .388 mCi                       .389 - .421 mCi Implanted

B712110004           .359 - .388 mCi                       .389 - .421 mCi Implanted

B701050102           .389 - .421 mCi                       .281 - .304 mCi Implanted

B701050103           .389 - .421 mCi                       .281 - .304 mCi Implanted

B701080101           .389 - .421 mCi                       .281 - .304 mCi Implanted

B701120103           .389 - .421 mCi                       .220 - .238 mCi Implanted

B701120105           .389-  .421 mCi                       .220 - .238 mCi Implanted

B712280001           .305 - .330 mCi                       .259 - .280 mCi Calibration

                                                             Seed (Disposed)

REASON: Labeled with wrong activity levels

MANUFACTURER/RECALLING FIRM: BEBIG ISOTOPENTECHNIK GMBH BERLIN,

RECALLED BY: UROMED CORP. NORWOOD, MA

DISTRIBUTION: NY, FL, TX

QUANTITY: 1208 SEEDS

 

PRODUCT AND CODE: a) Agilent Model M3500B Heartstream XLT Defibrillator, also labeled as:

Laerdal Heartstart 4000 Model M5500B Dibrillator/Monitor

b) Heartstream XL Model M4735A Defibrillator/Monitor

CODES: a) S/N range: US00100100-US101521; b) S/N range: US00100100-US00100778

REASON: Defibrillator may shut down or fail to power on

MANUFACTURER/RECALLING FIRM: Agilent Technologies Inc.,  Andover, MA

DISTRIBUTION: Nationwide

QUANTITY: 1338 units Heartstream XLT,  566 Heartstream XL

 

PRODUCT AND CODE: Superview Speedband Multiple Band Ligator and Injection; Superview Speedband Multiple Band Ligator Sterile                                                            

Codes:

UPN                    Descriptor              

M00542250      Superview 5 Band, Box 1

Lot Numbers: 613110A, 628120A, 625090A, 619100A, 601110B

M00542251         Superview 5 Band, Box

Lot Numbers: 608110A, 614110A, 617110A, 628110B, 604120A, 613120A, 614120A, 628120B, 605011A, 615011A,  620090A,

602100A, 604100A, 617100A, 620100A, 625100B

M00542280            Superview 8 Band, Box 1

Lot Numbers: 605011B, 602110A

M00542281            Superview 8 Band, Box 2   

Lot Numbers: 601120A, 604120B, 627120A, 615011B, 630100A, 601110A, 613110B, 615110A, 628110A

M00542150            Injection Superview 5 band w/o Needle

Lot Numbers: 603011B, 614100B, 618120A

M00542350            Injection Superview 5 band with Needle         

Lot Number: 3706692

M00542180            Injection Superview 8 band w/o Needle

Lot Numbers: 614100A, 618120B, 603011A

M00542380            Injection Superview 8 band with Needle

Lot Number: 3656041

REASON: Band ligator fails to deploy

MANUFACTURER/RECALLING FIRM: MEDSOURCE TECHNOLOGIES NEWTON, MA

RECALLED BY: Boston Scientific/Microvasive Endoscopy Div., Natick, MA

DISTRIBUTION: Nationwide and Japan, Europe

QUANTITY: 25,154 units                  

 

PRODUCT AND CODE: Model Nos. 501-4, 501-5, 501-6 Series, Deluxe LaserStar 501-4002 Nd:Yag, Hi Performance LaserStar Model 501-4002HP and Standard LaserStar Model No. 501-4003 Nd:Yag; laser welding products which are not medical devices:

Model No. 501-4xxx Series;

Model No. 501-5xxx Series;

Model No. 501-6xxx Series.

REASON: The products failed to have a readily available remote interlock connector.

MANUFACTURER/RECALLING FIRM: LaserStar Technology, Division of Crafford Precision Products Company, Riverside, RI

DISTRIBUTION: Nationwide and International

QUANTITY: 395 units

 

PRODUCT AND CODE: Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003;

Wako Lyophilized Chemistry 1, Product Code 1104A, Lot 7704A01, MFD Mar-00, Exp Date 31 Mar 2003.

REASON: Unit recalled by component manufacturer due to positive for anti-HCV.

MANUFACTURER/RECALLING FIRM: Bio-Rad Laboratories, Inc., Irvine, CA.

DISTRIBUTION: Japan

QUANTITY: Unknown.

 

PRODUCT AND CODE: Plum A+ Infusion Pump List No. 11973; Plum A+ Peripheral Card List No. 12380-04-05/06

CODES:   Abbott part number 11973; Abbott part number 12380-04-05/06 All lot/serial numners are involved.

REASON: There is a potential for error in delivery if Duration is changed while in “Titration Mode”.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories Abbott Park, IL

RECALLED BY: Abbott Laboratories, Hospital Products Division Morgan Hill, CA

DISTRIBUTION: Nationwide

QUANTITY: 4,060 units

 

PRODUCT AND CODE: Tosoh AIA-PACK brand Troponin I, Immunoassay Test Cups

Codes: Lot Numbers:  A719706; A919707; B119708; B319709

REASON: False positive and false negative results.

MANUFACTURER/RECALLING FIRM: TOSOH MEDICS, INC. SOUTH SAN FRANCISCO, CA

DISTRIBUTION: Nationwide and Canada, Chile and Mexico.

QUANTITY: 399 units

 

PRODUCT AND CODE: TracheoSoft, 8.0mm Shiley, XLT Distal Extension – Tracheostomy tube and tube cuff.  The product is an extended length tracheostomy tube that has a disposable inner cannula.  It is available in four sizes V 5, 6, 7 and 8mm and four different SKUs.  There are cuffed and uncuffed versions and proximal and distal versions of the above sizes.  Only the 8.0mm Shiley TracheoSoft XLT with Distal Extension - Cuffed Tracheostomy Tube is the subject of this recall.

CODES:   Catalog Number: 73120-080, Lot Number: 2001-01-4470

REASON: Device components can become disconnected or dislodged, leading to ineffective ventilation.

MANUFACTURER/RECALLING FIRM: Mallinckrodt Medical Athlone, Ireland,

RECALLED BY: NELLCOR PURITAN BENNETT, INC. Pleasanton, CA

DISTRIBUTION: U.S., Canada, U.K., Germany, Austria, Italy, Spain, Ireland. and France

QUANTITY: 560

 

PRODUCT AND CODE: Hamilton Disposable Precision Tips, A Microlab AT Series A pipette CODES:  Models:  235300, 235400

REASON: A defect in the molding of the tip barrel.

MANUFACTURER/RECALLING FIRM: Hamilton Co., Reno, NV.

DISTRIBUTION: AZ, NC, and NJ.

QUANTITY: 12 units

 

PRODUCT AND CODE: Dialysis Reverse Osmosis (RO) Water System, a water treatment system used in hemodialysis applications.

CODES:  The following RO serial numbers are affected by this recall: 97004, 97005, 97007, 97009-97019, 97021, 97024-97033, 97036, 97038,

97039, 97041-97043, 97045, 97048-97055, 97059, 97060-97066, 97069, 97070-97080, 97082, 97084-97086, 97088, 97089, 97093, 97095-97096, 97100,

97102, 97106, 97109, 97112-97114, 97117, 97123, 97124, 97127-97129.

REASON: The fuse holder may fail prematurely,  heat up, and result in a potential fire.

MANUFACTURER/RECALLING FIRM: AMERIWATER DAYTON, OH

DISTRIBUTION: Nationwide

QUANTITY: 85 units

 

PRODUCT AND CODE: FREEHAND System, Implantable Receiver-Stimulator (IRS) Electrodes for the NeuroControl FreeHand System.  The

system uses electrical muscle stimulation which is intended to improve a patient's ability to grasp, hold, and release objects. Codes:  Serial Numbers:  The five (5) units subject to recall were identified with the following Serial Numbers and Dates of Manufacture: Serial #92 and Serial #94, manufactured on 8/13/1996; and Serial Nos. 111, 114, and 115, manufactured on 1/29/1997.

REASON: The electrode device may fail to deliver proper stimulation to the patient.

MANUFACTURER/RECALLING FIRM: NEUROCONTROL CORP. VALLEYVIEW, OH

DISTRIBUTION: PA and CA.

QUANTITY: 5 units (not implanted)

 

PRODUCT AND CODE: STERIS 20 Sterilant Concentrate, used with the STERIS SYSTEM 1 PROCESS.  STERIS 20 is packaged in a cup consisting of two parts:  35% peracetic acid liquid and a dry powdered formulation (sterilant builders).  20 cups per carton.

Codes:  Catalog # S2000. The following 36 Lot Numbers are recalled: A424-01024, A426-01024, A427-01024, A427-01027, A431-01027,

A432-01027, A435-01027, A436-01027, A437-01027, A439-01027, A440-01027, A440-01103, A441-01103, A446-01103, A447-01103,

A448-01103, A450-01103, A451-01103, A452-01103, A454-01103, A455-01108, A456-01108, A458-01108, A464-01108, A466-01108,

A468-01114, A469-01114, A470-01114, A471-01114, A472-01114, A473-01114, A474-01114, A475-01114, A477-01114, A479-01114,

and A480-01114.

REASON: Metal particles may lodge in endoscope lumen and result in ineffective sterilization and/or may dislodge into patient during a surgical procedure.

MANUFACTURER/RECALLING FIRM: STERIS CORP. MENTOR, OH

DISTRIBUTION: Ntionwide and Canada

QUANTITY: 23748 cases (474,960 cups)

 

PRODUCT AND CODE: ENDOPATH Non-Bladed Obturator Trocar, with smooth or stability sleeve, handled or non-handled. Sizes: 5mm, 10/11mm, and 10/12mm. Lengths: 100mm and 75mm.  The defective Trocars are packaged as 6 per single sales unit per box or 2 to 5 units per procedure kit/tray. 

Codes: All finished packaging lot numbers are recalled. The lot numbers consist of a 6-digit number. 5mm size:  Distributed between December 1997 and December 2000, with expiration dates between December 2000 and November 2005.

10/11mm and 10/12mm sizes:  Distributed between December 1997 and September 2000, with expiration dates between December 2000 and August 2005.

The affected CATALOGUE NUMBERS [PRODUCT CODES] are as follows: Disposable Single Sales Unit, 5 mm [length 75 mm and 100 mm]:

35OL, 35HL, 35OS, 35HS, 35HST, 35NST, 35HLT, and 35NLT.

Disposable Single Sales Unit, 10/11 mm [length 100 mm]: 511O, 511H, 511NT, and 511HT.

Disposable Single Sales Unit, 10/12/mm [length 100 mm]: 512ON, 512HN, 512NT, and 512HT.

Resposable Single Sales Unit, 5 mm [length 100 mm]: 355NA, and 35LNA.

Resposable Single Sales Unit, 10/11 mm [length 100 mm]: 511HA, and 511NA.

Resposable Single Sales Unit, 10/12 mm [length 100 mm]: 512HA, and 512NA. 

Laparoscopic Cholecystectomy Trays: All numbers beginning with: FD, FDO, FNA, FNC, KDC, KNC, and VNC.

Laparoscopic Gastric Kits: All numbers beginning with: KNG, and FNG.

Laparoscopic OB/GYN Trays: All numbers beginning with: FNO, and KN.

Laparoscopic Hernia Trays: All numbers beginning with: FNH and KNH.

Laparoscopic Access/Basic Trays: All numbers beginning with: KNA.

Laparoscopic Bowel Trays: All numbers beginning with: KNB. 

REASON: The lens tip of the trocar may separate from the obturator during surgery.

MANUFACTURER/RECALLING FIRM: ETHICON ENDO-SURGERY, INC. Ciudad Juarez Chihuahua,MEXICO,

RECALLED BY: ETHICON ENDO-SURGERY, INC. CINCINNATI, OH

DISTRIBUTION: Nationwide and Worldwide

QUANTITY: 1,022,411 units

 

PRODUCT AND CODE: Product Name / Catalog Number / Lot Number:

1) Premier CMV IgG; Cat # CME100 Lots:  CME100.003, CME100.004, CME100.005

2) Premier CMV IgM; Cat # CME150 Lots:  CME150.002, CME150.003, CME150.004

3) Premier EBV Early Antigen IgG; Cat # EAI101 Lots:  EAI101.005, EAI101.007, EAI101.008

4) Premier EBV VCA IgG; Cat # EBE100 Lots:  EBE100.004, EBE100.005, EBE100.008, EBE100.009, EBE100.010

5) Premier EBV VCA IgG SemiQuantitative; Cat # EBE101 Lots:  EBE101.009, EBE101.011, EBE101.012

6) Premier EBV VCA IgM; Cat # EBE150 Lots:  EBE150.005, EBE150.009, EBE150.011, EBE150.012

7) Premier EBV EBNA-1 IgG; Cat # ENE102 Lots:  ENE102.004, ENE102.007, ENE102.008

8) Premier EBV VCA/EA IgM; Cat # EVE150 Lots:  EVE150.005, EVE150.006           

9) Premier HSV Type 1 IgM; Cat # H1E150 Lots:  H1E150.008                    

10) Premier Type Specific HSV-1 IgG; Cat # H1I101 Lots:  H1I101.008, H1I101.009

11) Premier Type Specific HSV-1 IgG; Cat # H1S100 Lots:  H1S100.007, H1S100.008, H1S100.009

12) Premier HSV Type 2 IgM; Cat # H2E150 Lots:  H2E150.004, H2E150.007, H2E150.008, H2E150.009, H2E150.010

13) Premier Type Specific HSV-2 IgG; Cat # H2I101 Lots:  H2I101.005, H2I101.007, H2I101.008

14) Premier Type Specific HSV-2 IgG; Cat # H2S100 Lots:  H2S100.005, H2S100.007

15) Premier Type Specific HSV-1 & 2 IgG; Cat # H3I101 Lots:  H3I101.002, H3I101.003          

16) Premier Lyme IgM; Cat # LDE150 Lots: LDE150.004, LDE150.005, LDE150.006

17) Premier Rubeola IgG; Cat # RBE100 Lots:  RBE100.003, RBE100.004

18) Premier Rubeola IgM; Cat # RBE150 Lots:  RBE150.004, RBE150.005  

19) Premier Rubella IgG; Cat # RUE100 Lots:  RUE100.004, RUE100.005   

20) Premier Rubella IgM; Cat # RUE150 Lots:  RUE150.002, RUE150.003  

21) Premier Rubella IgG; Cat # RUE101 Lots:  RUE101.003, RUE101.004   

22) Premier Toxoplasma IgG; Cat # TXE100 Lots:  TXE100.002, TXE100.003

23) Premier Toxoplasma IgG; Cat # TXE101 Lots:  TXE101.001                  

24) Premier Toxoplasma IgM; Cat # TXE150 Lots:  TXE150.001, TXE150.002          

25) Premier VZV IgG; Cat # VZE101 Lots:  VZE101.005, VZE101.006          

CODES:   All lot numbers still within expiration dates.

REASON: The kits are not properly validated, which may give variable or inaccurate test results.

MANUFACTURER/RECALLING FIRM: MERIDIAN DIAGNOSTICS, INC. CINCINNATI, OH

DISTRIBUTION: Nationwide and  Italy, Canada, Columbia, Mexico, New Zealand, Philippines, Costa Rica, Panama, Germany, Belgium, West Indies, Australia, Venezuela, and Switzerland.

QUANTITY: 20,286 kits

 

PRODUCT AND CODE: 2.4mm Locking Screws, component/accessory of the Osteomed Rigid Fixation System - Mandibular Frature/Reconstruction System. Codes:    Recalled accessory is not coded on the packaging.

Part Number          Lot Number           Qty

206-0206                 994262                     204

206-0208                 884263                     205

206-0210                 994264                     392

206-0212                 994265                     404

206-0214                 994266                     407

206-0218                 994268                     200

206-0216                 994267                     209

206-0220                 994269                     204

206-0222                 994270                    208

REASON: The locking screw can fracture/break during surgical procedure.

MANUFACTURER/RECALLING FIRM: OSTEOMED CORP. ADDISON, TX

DISTRIBUTION: Canada, Norway

QUANTITY: 2434

 

PRODUCT AND CODE:

a) Aaron Ball Electrode, 5mm;

b) PSS Ball Electrode 5mm;

c) Sklar Ball Electrode 5mm;

d) Apple Medical Ball Electrode 5 mm.

CODES: a) Cat. Number ES07, Lot Numbers 2000-11-09, 2000-11-30 and 2000-12-14;

b) Cat Number 465, Lot numbers 1100-B, 1200-B and 0101-B

c) Catalog Number 96-1045, Lot Number 0101-A,

d) Catalog Number 900-163, Lot numbers 1000-D, 1100-D and 0101-B.

REASON: Electrode fell apart during use.

MANUFACTURER/RECALLING FIRM: Aaron Medical Industries, St. Petersburg, FL

DISTRIBUTION: Nationwide, and Canada, New Zealand, and Spain

QUANTITY: 4,249

 

PRODUCT AND CODE: Clinitron At-Home Air Fluidized Therapy Codes:   Model CS (also identified as model #C-6) - All serial numbers

REASON: Power cords overheating, smoking, or melting during normal operations.

MANUFACTURER/RECALLING FIRM: Hill-Rom, Inc. Charleston, SC

DISTRIBUTION: Nationwide

QUANTITY: 2873 units (1799 in patient homes & 1074 in service centers)              

 

PRODUCT AND CODE: VasoSeal VHD Device; Bascular Hemostasis device Catalog number 75304

CODES:   VasoSeal VHD Device, Kit #4 Device Listing:  A063825 Catalog Number 75304 Manufacturing Lot Number:03051172

REASON: Portion of VasoSeal VHD lot shipped prior to receipt of complete pyrogen testing.

MANUFACTURER/RECALLING FIRM: Datascope Corp. Collagen Products Division Mahwah, NJ

DISTRIBUTION: Nationwide

QUANTITY: 180 units

 

PRODUCT AND CODE: Datascope's Percor STAT-DL and True Sheathless 9.5 Fr.Intra-Aortic Balloon Catheter for optional Sheathless Insertion.

CODES:   Product Numbers: 0684-00-0255-0X, 0884-00-4031-0X, 0684-00-0256-0X, 0684-00-0270-0X; 0884-00-3431-0X, 0684-00-0343-0X,

0784-00-0138-0X, 0884-00-2513-0X Lot Identification: 995, 996, 997, 997A

REASON: Defect in the Y-fitting component which could cause slow gas leak.

MANUFACTURER/RECALLING FIRM: DataScope Corp. Fairfield, NJ.

DISTRIBUTION: National and International

QUANTITY: 590 units

 

PRODUCT AND CODE: Valleylab LigaSure vessel sealing system, CODES:  Catalog Number: LS1000, Lot ANH000503.

REASON: Previously recalled product, not released for distribution, was distributed.

MANUFACTURER/RECALLING FIRM: Valleylab, Inc., Boulder, CO

DISTRIBUTION: CA, CO, and PA

QUANTITY: 18 units

 

PRODUCT AND CODE: All products bearing the Hydrocath trademark.  Products manufactured from 1996 until 1998 were labeled as Ohmeda Hydrocath Central Venous Catheters. In 1998, BD acquired Ohmeda and labeling will indicate BD Hydrocath Central Venous Catheters.

CODES:    Becton Dickinson reference numbers 681173 thru 681222, 681275 thru 681278. All catheters labeled as BD Hydrocath or Ohmeda

Hydrocath.

REASON: Immediate-type hypersensitivity reactions, primarily in pediatric/infant patient

MANUFACTURER/RECALLING FIRM: BD Critical Care Systems PTE LTD Singapore,

RECALLED BY: Becton Dickinson Infusion Therapy Systems, Inc. Sandy, UT

DISTRIBUTION: Nationwide and Mexico, Japan, and other European countries not yet furnished.

QUANTITY: Approximately 2,135,000 units

 

PRODUCT AND CODE: a) Kendall SCD Clear Sequel/SCD Response Tubing Assembly    used with Model 6325 and 7325;

b) Kendall SCD Blue Quick-Lock Tubing Assembly used with     Models 5320 and 5325

CODES: a) Product Code: 6328 Lot Numbers: 118761, 118762, 118763, 119574

b) Product Code: 5378A Lot Number: 119571

REASON: Tubing Assemblies assembled incorrectly and compression sleeves may not inflate properly.

MANUFACTURER/RECALLING FIRM: THE KENDALL CO. LP ARGYLE, NY

RECALLED BY: THE KENDALL CO. LP MANSFIELD, MA

DISTRIBUTION: Nationwide

QUANTITY: #6328= 590 eaches; #5378=7 eaches        

 

PRODUCT AND CODE: Lifescan brand One Touch Hospital Blood Glucose Test Strips, 50-count test strips in a package.

CODES:  Lot 009894A, Exp. Date:  09/02

REASON: The product was assigned an incorrect calibration code (“calcode”).

MANUFACTURER/RECALLING FIRM: LifeScan, Inc, Milpitas, CA

DISTRIBUTION: Nationwide

QUANTITY: 2224 units

 

PRODUCT AND CODE: Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the

Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]. The software is responsible for conveting OSP files into a format for use by Medusa 2000.

CODES:   Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3

REASON: Software may process result instead of invalidating the plate

MANUFACTURER/RECALLING FIRM: SANGUIN INTL., INC. STAFFORDSHIRE DE 13  8AX,

RECALLED BY: SANGUIN INTL., INC. HAMDEN, CT

DISTRIBUTION: AL and TN

QUANTITY: 2

 

PRODUCT AND CODE: Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05

when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05

REASON: Incorrect Visual Display

MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL, INC. BEAVERTON, OR

DISTRIBUTION: Nationwide and Netherlands, France, and Canada

QUANTITY: 198

 

PRODUCT AND CODE: AutoSuture [Single use Staplers] as follows:

CODES: a) ILA* 75-3. 8     Order Code 4914     Affected Lot Numbers: P0M456, P1A104, P1A132, P1A199,     P1B246, P1B247, P1C382, P1C592, P1C615, P1C680, P1E96,     P1B248R

b) ILA* 75-4.8     Order Code 4916     Affected Lot Numbers: P1A166, P1A273, P1D66

c) ILAN* 75-4.8 (Non anastomotic) Order Code 4917     Affected Lot Number: P1A390

REASON: Stapler may fire without the staples being completely formed into the tissue

MANUFACTURER/RECALLING FIRM: USSC Puerto Rico, Inc. Mercedita, PR

RECALLED BY: United States Surgical Corp. North Haven, CT

DISTRIBUTION: Nationwide and Canada, Japan, Korea, Singapore, Switzerland, Austria.

QUANTITY: 7967               

 

PRODUCT AND CODE: Maquet Alphamaxx Surgical Tables, Model 1133 CODES:  Serial Numbers 11, 12, 14, 16, 17, 18

REASON: Table did not elevate when the Table-Up function was activated

MANUFACTURER/RECALLING FIRM: Maquet Aktiengesellschaft Rastatt, Germany,

RECALLED BY: Getinge/Castle, Inc. North Charleston, SC

DISTRIBUTION: CA, CO and IL.

QUANTITY: 13 tables

 

PRODUCT AND CODE: Maquet Surgical Table, Model C-Max

CODES:     AR001011, AR001012, AR001013, AR001014, AR001015, AR001016, AR001017, AR001018, AR001019, AR001020, AR001021, AR001022, AR001024, AR001026, AR001027, AR001028, AR001029, AR001030, AR001031, AR001032, AR001033, AR001034, AR001035, AR001036, AR001037, AR001038     

REASON: There is a potential of allowing the patient's head to drop.

MANUFACTURER/RECALLING FIRM: ALM Orleans CEDEX 2, France,

RECALLED BY: Getinge/Castle, Inc. North Charleston, SC

DISTRIBUTION: GA, MD, PA, TN, TX & WA

QUANTITY: 26 tablets

 

PRODUCT AND CODE: Respironics Noninvasive Extrathoracic Ventilator NEV-100 CODES: NEV-100(Noninvasive Extrathoracic Ventilators), all serial numbers manufactured between 4/1992 and 2/1999.

REASON: Faulty RFI filter may cause device to stop, reset and/or exhibit a smoky odor.

MANUFACTURER/RECALLING FIRM: Respironics Colorado, Inc. Westminster, CO

DISTRIBUTION: Nationwide and Australia, Brazil, Canada, China, Egypt, France, Germany, Greece, India, Italy, Japan, Korea, Mexico, and Taiwan.

QUANTITY: 448 units

 

PRODUCT AND CODE: Acuity Central (Monitoring) Station 

CODES:   FW03140982 through FW04330603 and TW03049094 through TW03049286

REASON: System crashes and lock-up.

MANUFACTURER/RECALLING FIRM: Welch Allyn Protocol, Inc. Beaverton, OR

DISTRIBUTION: AZ, CA, DE, IN, KY, NC, NJ, OH, PA, and TX. Singapore, Belgium, Egypt, Poland, New Zealand

QUANTITY: 43

 

PRODUCT AND CODE: Siemens Compressor Compact, 115V/60Hz

CODES:  Part Number: 61 50 440 EH81E, Serial numbers: 20001-20962

REASON: Defective clutch in the compressor may result in low pressure alarm or noisy units

MANUFACTURER/RECALLING FIRM: Siemens Elema AB/Electromedical Division SOLNA,

RECALLED BY: Siemens Medical Systems, Inc. Danvers, MA

DISTRIBUTION: Nationwide

QUANTITY: 854 units clutch replacement/972 units for F3 Fuse               

 

PRODUCT AND CODE: Catheter Innovations PASV Implantable Port (plastic) Single or Dual port.

CODES:  Catalog No's:  PRTC66P, PRTC96P, PRTD10P, PRTC66A, PRTC96A, PRTD10A.  All lots.

REASON: Implantable plastic catheter ports may leak due to cracking.

MANUFACTURER/RECALLING FIRM: Catheter Innovations, Inc. Salt Lake City, UT

DISTRIBUTION: Nationwide and Belgium, Canada, Italy, UK, and Turkey.

QUANTITY: 180 units

 

PRODUCT AND CODE: Enteral Feeding Tube, Preassembled with Stylet, size 10 French 45 inch (114 cm), non-sterile, 10 feeding

tube units per case.

CODES:   Lot Numbers:  59233ZU01, 60273ZU01, 62020ZU01. Ross List Number:  55041.

REASON: Stylet may extend beyond the tip of the tube and cause tissue damage.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc., Laurinburg, NC

RECALLED BY: Ross Products Division, Abbott Laboratories, Inc. Columbus, OH 

DISTRIBUTION: Nationwide

QUANTITY: 303 cases

 

PRODUCT AND CODE: Bard Access Opti-Flow Pre-Curved Dual Lumen Catheters, and Bard Access Opti-Flow Straight Chronic Dual Lumen Catheters

CODES:  All of the following are "Opti-Flow" dual lumen catheters.

TRAYS

5636192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lots 36HK0035, 36IK0077, 36KK0065

5636232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lot 36LJ0066

KITS

5634150 "Pre-Curved" 15 cm Insertion Length Lot 22JKA184

5634152 "Pre-Curved" 15 cm Insertion Length with VitaCuff Lots 22BLA627, 22JKA179

5634190 "Pre-Curved" 19 cm Insertion Length Lots 22ALA621, 22DKA129

5634192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lots 22AKM021, 22AKM022, 22ALA617, 22LJM005, 22DKA125,         22DKA131, 22FKA139, 22GKA146, 22GKA147, 22HKA162, 22HKA165, 22JKA178, 22AKM024.

5634230 "Pre-Curved" 23 cm Insertion Length Lots 22FKY005, 22FKY006, 22HKA159, 22HKA163, 22JKA194.

5634232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lots 22BLY030, 22EKA132, 22EKA134, 22FKY003, 22GKA140, 22LKA609.

5634270 "Pre-Curved" 27 cm Insertion Length Lots 22JKA188, 22KKA199.

5634272 "Pre-Curved" 27 cm Insertion Length with VitaCuff Lot 22IKA169.

CATHETERS ONLY

5632150 "Pre-Curved" 15 cm Insertion Length Lot 22JKA183.

5632190 "Pre-Curved" 19 cm Insertion Length Lots 22HKA158, 22DKA128, 22GKY009.

5632192 "Pre-Curved" 19 cm Insertion Length with VitaCuff Lot 22HKA161.

5632230 "Pre-Curved" 23 cm Insertion Length Lot 22LJM010.

5632232 "Pre-Curved" 23 cm Insertion Length with VitaCuff Lot 22LJM012.

5632270 "Pre-Curved" 27 cm Insertion Length Lot 22AJK189.

TRAYS

5635692 "Straight" 19 cm Insertion Length with VitaCuff Lots 36AKO036, 36HKO036, 36IKO070.

5635732 "Straight" 23 cm Insertion Length with VitaCuff Lots 36BLO051, 36LJO048, 36JKO064.

KITS

5633150 "Straight" 15 cm Insertion Length Lots 22ALA127, 22JKA181.

5633152 "Straight" 15 cm Insertion Length with VitaCuff Lot 22JKA180.

5633270 "Straight" 27 cm Insertion Length Lots 22BLA629, 22JKA191, 22KKA603.

5633272 "Straight" 27 cm Insertion Length with VitaCuff Lot 22JKA192.

5633690 "Straight" 19 cm Insertion Length Lots 22EKA135, 22LJM006, 22FKY004.

5633692 "Straight" 19 cm Insertion Length with VitaCuff Lots 22KJM002, 22EKA202, 22DKA126, 22EKY002, 22FKA137, 22GK3439, 22GK3440, 22HJM707, 22HJM708, 22HKA152, 22IKA171.

5633730 "Straight" 23 cm Insertion Length Lots 22ALA620, 22DKA123, 22IJM726, 22LJM007.

5633732 "Straight" 23 cm Insertion Length with VitaCuff Lots 22BLA631, 22LJM017, 22DKA127, 22EKA200, 22EKY001, 22FKA136, 22FKA138, 22HKA156, 22IJM734, 22IKA167, 22IKA174, 22LJM009, 22LJM016.

CATHETERS ONLY

5631550 "Straight" 15 cm Insertion Length Lot 22JKA182.

5631690 "Straight" 19 cm Insertion Length        22DKA124.

5631692 "Straight" 19 cm Insertion Length with VitaCuff  Lot 22EKA201, 22LJM011.

5631730 "Straight" 23 cm Insertion Length Lots 22GK3454, 22HKA154.

5631732 "Straight" 23 cm Insertion Length with VitaCuff Lot IJM733.

5631770 "Straight" 27 cm Insertion Length Lots 22JKA190, 22GKY007, 22GKY008.

5631850 "Straight" 35 cm Insertion Length Lots 22JKA185, 22CKA111, 22EKA133, 22KKA602.

REASON: Catheter tips may separate during use.

MANUFACTURER/RECALLING FIRM: Medron, Inc. Salt Lake City, UT

RECALLED BY: Bard Access Systems, Salt Lake City, UT

DISTRIBUTION: Nationwide to all states except ME and VT. Foreign distribution to Canada and Australia.

QUANTITY: 47,757 units  

 

PRODUCT AND CODE: Medex 60-inch Low-Vol Extension Set with Female Luer Lock, Male Luer Lock, and Non-Removable Slide Clamp.  The product is packaged as 50 units per case, and labeled in part, ' ** Medex - A Furon Company Hilliard, OH  43026 USA ** PRODUCT 536035 ** 60in/152cm Ext. W/M/FLL  Clamp APV 1.0 ml ** Latex Free ** STERILE ** ' CODES:    Lot Number:  31A290143

REASON: The immediate container is labeled with the incorrect product number/priming volume.

MANUFACTURER/RECALLING FIRM: Medex, Inc. Hilliard, OH

RECALLED BY: Medex, Inc., Dublin, OH

DISTRIBUTION: Nationwide

QUANTITY: 200 cases (10,000 units)              

 

PRODUCT AND CODE: Amsco Reliance 444 Washer-Disinfector, single-chamber. 

CODES:   Serial Numbers:  3601900003, 3601900004, 3604100008, 3605901035, and 3609401004.

REASON: An electrical shock hazard may exist due to improper ground wiring.

MANUFACTURER/RECALLING FIRM: STERIS CANADA CORP. BEAUPORT, QUEBEC,

RECALLED BY: STERIS CORP. MENTOR, OH

DISTRIBUTION: NY, PA, NJ, and DE.

QUANTITY: 5 units

 

PRODUCT AND CODE: AutoDose Pump, Model P4120, an External Infusion Pump

CODES:   The firm provided a list of serial numbers affected but they are nonsequentially assigned to various consignees.

REASON: Rollers in pump may pinch fingers of caregiver.

MANUFACTURER/RECALLING FIRM: Tandem Medical San Diego, CA

DISTRIBUTION: Nationwide

QUANTITY: 249

 

PRODUCT AND CODE: FluidSense Sterile Administration Sets as follows: The sets are used with the FluidSense Fluid Delivery

System  [FS-01].

CODES:  

ES-O5 Secondary Administration Set -P/N 100324

ES-06 Large Volume Extension Set- P/N 100325

ES-07 Large Volume Administration Set- P/N 100326

ES-08 Low Contain Volume (Pedatric) Adminstration P/N 102191 All lots

REASON: Core Y-Site may separate from plastic housing and dislodge

MANUFACTURER/RECALLING FIRM: Elcam Paltics Merom Hagali, Israel

RECALLED BY: Fluidsense Corp. Newburyport, MA

DISTRIBUTION: CA, FL, TN,

QUANTITY: 19,840

 

PRODUCT AND CODE: Clinical Information Center Software.  The brand name was Marquette when the product was initially distributed.

CODES:   All devices with V.2 and later revisions of the software.

REASON: Device can improperly restart resulting in no alarms or information at the central station for 2 minutes.

MANUFACTURER/RECALLING FIRM: GE Medical Systems, Information Technologies, Milwaukee, WI

DISTRIBUTION: Nationwide and worldwide.

QUANTITY: 645 units       

 

PRODUCT AND CODE: StarBurst Screw Driver.  This medical device is a screwdriver designed for use with the firm’s MacroPore System. The MacroPore System consists of resorbable implants and accessories for bone healing applications. The catalog numbers affected are 02090.  The devices from this catalog number were sold in sterile and non-sterile forms.   Only the sterile units were subject to the removal.

REASON: False perception of sterility on part of users.

MANUFACTURER/RECALLING FIRM: MACROPORE, INC. SAN DIEGO, CA

DISTRIBUTION: TN

QUANTITY: 62

 

 PRODUCT AND CODE: Allograft Heart Valve

CODES:  Model No. AV05 - Serial Number 3877299; Model No. PV05 - Serial Number 3871398

REASON: Failure to meet curent guidelines regarding serodilution of plasma.

MANUFACTURER/RECALLING FIRM: CRYOLIFE, INC. KENNESAW, GA

DISTRIBUTION: MD and OK

QUANTITY: 2 units

 

PRODUCT AND CODE: Polysynthane Hemodialyzers; 24 units per case; The products were distributed under both the Baxter label: Baxter Healthcare Corporation, Renal Division, Deerfield, IL 60015, and the Gambro label: the following models are affected:

a) Model PSN-170, 1.7 m2 surface area x 229 mm length product code 5M1817 - Baxter label, global multi-language 5Q6123 - Baxter Japanese label 5M4117 - Gambro label

b) Model PSN-210, 2.1 m2 surface area x 229 mm length product code 5M1818 - Baxter label, global multi-language 5Q6124 - Baxter Japanese label 5M4118 - Gambro label

Codes: All lots of the PSN 170 and PSN 210 dialyzers

a) Model PSN-170, 1.7 m2 surface area x 229 mm length product code 5M1817 - Baxter label, global multi-language 5Q6123 - Baxter Japanese label 5M4117 - Gambro label

b) Model PSN-210, 2.1 m2 surface area x 229 mm length product code 5M1818 - Baxter label, global multi-language 5Q6124 - Baxter Japanese label 5M4118 - Gambro label

REASON: Fiber blood leaks

MANUFACTURER/RECALLING FIRM: BAXTER HEALTHCARE CORP. MOUNTAIN HOME, AR

RECALLED BY: BAXTER HEALTHCARE CORP. DEERFIELD, IL

DISTRIBUTION: Nationwide and Canada, Ecuador, Greece, Venezuela, Colombia, Belgium, Sweden, Mexico, Australia, Argentina, Shanghai and Germany                        

QUANTITY: 1,239,047 units

 

PRODUCT AND CODE: Medtronic Activa Tremor Control Systems, also called Medtronic Activa Systems For Deep Brain Stimulation (DBS).  Each consists of a neurostimulator or pulse generator, an extension, and a lead, which are used for the treatment of tremor due to Parkinson's Disease and Essential Tremor.  Identified below are the specific pulse generators, extensions, and leads that can be used: 

Medtronic Generators Itrel I, II and 3 Implantable Pulse Generators Models 7420, 7421, 7424, 7425.  

Medtronic Soletra Quadripolar Neurostimulator for Deep Brain Stimulation, Model 7426

Medtronic Model 7495 DBS Extension For Stimulation of the Brain, Codes:  All lots and serial numbers

REASON: Using diathermy to treat patients with neurostimulation devices can cause injury

MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC. MINNEAPOLIS, MN

DISTRIBUTION: Nationwide and worldwide                 

QUANTITY: An estimated 65,000 patients (6500 DBS patients) have Medtronic neurostimulation devices.                    

 

PRODUCT AND CODE: Becton Dickinson Saf-T-Intima IV Catheter.  Catalog No. 383323, Lot 101322, and Catalog No. 383336, Lot 101328 and 101329.  Codes: Catalog Number 383323, Lot 101322. Catalog Number 383336, Lot 101328, 101329

REASON: The telescoping needle shield would not function as designed due to improper epoxy application during manufacture.  As a needle is withdrawn, the needle shield is supposed to telescope over the needle to prevent the possibility for needle sticks.

MANUFACTURER/RECALLING FIRM: Becton Dickinson Infusion Therapy Systems Inc. Sandy, UT

DISTRIBUTION: Nationwide

QUANTITY: 9,200 units

 

PRODUCT AND CODE:

a) Codman SiphonGuard CSF Control Device S/N 883944

b) CodmanHakim Programmable Valve, In-Line Reservoir Separable Distal Catheter with SiphonGuard Device

c) CodmanHakim Programmable Valve, with Right Angle Reservoir, Separable Distal Catheter with SiphonGuard Device

d) CodmanHakim Programmable Valve, In-Line Reservoir Unitized Distal Catheter with SiphonGuard Device

e) CodmanHakim Programmable Valve with Right Angle Reservoir Unitized Distal Catheter with SiphonGuard Device

CODES:

a) Catalog # 82-3090 [Stand-Alone]

b) Catalog # 82-3132 Lot numbers: beginnning with PP, PN

c) Catalog # 82-3136 Lot numbers: beginnning with PP, PN

d) Catalog # 82-3142 Lot numbers: beginnning with PP, PN

e) Catalog 3 82-3146 Items B-D are serialized, all serial numbers begin with PP or PN

REASON: Device may activate at lower than intended flow rates

MANUFACTURER/RECALLING FIRM: SARL CODMAN LELOCLE SWITZERLAND, 

RECALLED BY: CODMAN & SHURTLEFF INC RAYNHAM, MA

DISTRIBUTION: Nationwide and Australia, Egypt, New Zealand, Spain, UAE, England

QUANTITY: 215                 

 

PRODUCT AND CODE: Brand Name: Dall Miles Vitallium Cable Crimp Sleeve Common Name:Cable Crimp Sleeve

Classification Name:Appliance, fixation, nail/blade/plate combination Multiple Component

Codes:  Part Number  Description         6704-0-410   Small Vitallium Cable Sleeve  Plus 1.6mm Cable

Lot # ILUX01, ILUY01, ILUZ01, ILVA01, ILVB01, ILVC01, ILVD01, IMDMO1, IMDN01, IMDO01, IMDP01, IMDR01, IMDS01,

                6704-0-420   Small vitallium Cable Sleeve Plus 1.6mm Beaded Cable

Lot # ILUP01, ILUR01, ILUS01, ILUT01, ILUU01, ILUV01, ILUW01, IMAF01, IMAG01, IMAH01, IMAI01,

         6704-0-510   Medium Vitallium Cable Sleeve Plus 2.0mm Cable

Lot # ILPO01, ILPP01, ILRF01, IJMA01, IJMB01, IJMC01, IJMD01, IJME01, ILLW01, ILNU01, ILNV01, ILNW01, ILNX01, ILNY01,

ILNZ01, ILOA01, ILPJ01, ILPK01, ILPL01, ILPM01, ILPN01, ILRG01, ILRH01, ILRI01, ILRJ01, ILRK01, ILRL01, ILRZ01, ILSA01A,ILSB01, ILSC01, ILSD01, ILSE01, ILSF01, ILSV01, ILSWO1, ILSX01, ILSY01, ILSZ01, ILTA01, ILTB01, ILUA01, ILUB01, ILUC01, ILUD01, ILUE01, ILUF01, ILUG01, ILWS01, ILWT01, ILWU01, ILWW01, ILWX01, ILWY01, ILXA01, ILXB01, ILXC01, ILXD01, ILXE01, ILXF01, ILXG01, ILYN01, ILYO01, ILYP01, ILYR01, ILYS01, ILYT01, ILYU01, ILYV01, ILYW01, ILYX01, ILYY01, ILYZ01, ILZA01, ILZB01, ILZR01, ILZS01,

ILZT01, ILZU01, ILZV01, ILZW01, ILZX01, IMBE01, IMBF01, IMBG01, IMBH01, IMBI01, IMBJ01, IMBK01, IMBT01, IMBU01,

IMBV01, IMBW01, IMBX01, IMBY01, IMBZ01, IMDF01, IMDG01, IMDH01, IMDI01, IMDJ01, IMDK01, IMDL01, IMEO01, IMEP01,

IMER01, IMES01, IMET01, IMEU01, IMEV01, IMFD01, IMFE01, IMFF01, IMFG01, IMFH01, IMFI01, IMFJ01, IMHC01, IMHD01,

IMHE01, IMHJ01, IMHK01, IMHL01, IMHR01, IMHS01, IMHT01, IMHU01, IMHV01, IMHW01, IMHX01, IMJI01, IMJJ01, IMJK01,

IMJL01, IMJM01, IMJN01, IMJO01,

       6704-0-520   Medium Vitallium Cable Sleeve Plus 2.0mm Beaded Cable

Lot # ILLN01, ILLO01, ILLR01, ILLS01, ILLT01, ILLU01, ILNM01, ILNN01, ILNO01, ILNP01, ILNR01, ILNS01, ILNT01, ILPR01,

ILPS01, ILPT01, ILPU01, ILPV01, ILPW01, ILRS01, ILRT01, ILRU01, ILRV01, ILRW01, ILTX01, ILRY01, ILTC01, ILTD01,

ILTE01, ILTF01, ILTG01, ILTH01, ILTI01, ILUI01, ILUJ01, ILUK01, ILUL01, ILUM01, ILUN01, ILUP01, ILXH01, ILXI01,

ULXJ01, ILXK01, ILXL01, ILXM01, ILXN01, ILZY01, ILZZ01, IMAA01, IMAB01, IMAC01, IMAD01, IMAE01, IMBL01, IMBM01,

IMBN01, IMBO01, IMBP01, IMBR01, IMBS01, IMCA01, IMCC01, IMCD01, IMCE01, IMCF01, IMCG01, IMEW01, IMEX01, IMEY01,

IMWZ01, IMDW01, IMDX01, IMDY01, IMFK01, IMFL01, IMFM01, IMFN01, IMFO01, IMFP01, IMFR01, IMHF01, IMHG01, IMHH01,

IMHI01, IMHM01, IMHN01, IMHO01, IMHP01, IMIU01, IMIV01, IMIW01, IMIX01, IMIY01, IMIZ01, IMIJA01

        6704-4-016   Small Cable Sleeve 1.6mm Lot # CCAEBH

       6704-4-020   Medium Cable Sleeve 2.0mm

Lot# CAUUF, CAUUH, CAUUI, CAUUJ, CAUUK, CAUUM, CAUUN, CAUUO, CAUUG, CAUUP, CAUUR, CAUUS, CAUUT, CAUUU, CCAETA, CCAETJ, CCAETB, CCAETC, CCAETD, CCAETE, CCAETF, CCAETG, CCAETH, CCAETI, CCAEYA, CCAEYJ, CCAEYB, CCAEYC, CCAEYD, CCAEYE, CCAEYF, CCAEYG, CCAEYH, CCAEYI, CCAFCE, CCAFCN, CCAFCF, CCAFCG, CCAFCH, CCAFCI, CCAFCK, CCAFCL, CCAFCM, CCAFHG, CCAFHH, CCAFHI, CCAFHJ, CCAFHK, CCAFHL, CCAFHM, CCAFJV, CCAFJW, CCAFJX, CCAFJY, CCAFJZ, CCAFNK, CCAFNU, CCAFNL, CCAFNM, CCAFNN, CCAFNO, CCAFNP, CCAFNR, CCAFNS, CCAFNT, CCAFRU,

CCAFRV, CCAFRW, CCAFRX, CCAFRY, CCAFRZ, CCAFUP, CCAFUR, CCAFUS, CCAFUT, CCAFUU, CCAFUZ, CCAFUW, CCAFUX, CCAFUY, CCAFZC, CCAFZL, CCAFZD, CCAFZE, CCAFZF, CCAFZG, CCAFZH, CCAFZI, CCAFZK, CCAGDA, CCAGDB, CCAGDC, CCAGDD, CCAGDJ, CCAGDE, CCAGDF, CCAGDG, CCAGDH, CCAGDI

REASON: Cable crimp sleeves not heat treated which can cause fracture during crimping

MANUFACTURER/RECALLING FIRM: HOWMEDICA OSTEONICS CORP. RUTHERFORD, NJ

DISTRIBUTION: Nationwide and Australia, Sweden, Germany, Canada, Chile, China, Holland, France, Spain, Italy, Japan, New Zealand, and United Kingdom.

QUANTITY: 8914                               

 

PRODUCT AND CODE: Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures

Codes: a) Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 thru 2016

b) Model 4380221 - E.CAM Gantry Dual Head, serial numbers 0005 thru 2038, and 31827

Model 5242826 - E.CAM Gantry Dual Head, serial numbers 1001 thru 2012

REASON: Resistor Packs installed backwards cause software errors

MANUFACTURER/RECALLING FIRM: SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL

DISTRIBUTION: Nationwide and International

QUANTITY: 229 units

 

PRODUCT AND CODE: MAC Two Lumen Central Venous Access Kit/Set. Codes:catalog #AK-11142 - Lots: RF1020751, RF1031739, RF1031850, RF1033089, RF1043328, and RF1044374. Catalog  #SI-11142 - Lots: RF0126277, RF1031741, and RF1043329.

REASON: Potential for leakage of fluid or air from hemostasis valve w/obturator in place

MANUFACTURER/RECALLING FIRM: ARROW INTL., INC. READING, PA

DISTRIBUTION: Nationwide and Germany, Auckland, England, Athens, South Africa, Japan, England, Caracas.

QUANTITY: 4710 kits        

 

PRODUCT AND CODE: "Reli On" Insulin Syringe, 3/10 cc, 30 gauge 5/16" (8mm) Needle (sterile).Labeled: "ULTRA COMFORT SHORT NEEDLE Insulin Syringes Reli On  U-100 Insulin for 30 Units or Less***3/10cc***". Packed in boxes of 100 Single Use Syringes

CODES: Lot number: 374317; Exp. Date: 4/06

REASON: Insulin Syringes Mislabeled as 3/10cc, 30 unit instead of 1/2cc, 50 unit

MANUFACTURER: KENDALL/DIV. OF TYCO HEALTHCARE GROUP LP NORFOLK, NE

RECALLED BY: KENDALL/ A DIVISION OF TYCO HEALTHCARE MANSFIELD, MA

FIRM INITIATED RECALL: Kendall notified WalMart, Bentonville, AR

DISTRIBUTION: Nationwide.

QUANTITY: 400,200 syringes          

 

PRODUCT AND CODE: Olympus Uteromat Fluid Control model A4058. Designed for infusion of low viscosity distension media during

hysteroscopic procedures to distend the cavum uteri (uterine cavity). Device provides constant monitoring and display of inflow fluid volume and fluid loss, permanent measuring of fluid consumption automatic calculation of the total amount of fluid loss, additional warning for rapid absorption.

Codes:  Serial Numbers: 0006CM268 - 0006CM272, 0011CM286 – 0011CM295, 0101CM027 – 0101CM031, 0101CM476 – 0101CM480, 9606CE087 – 9606CE104, 9607CE336 – 9607CE345, 9701CE081 – 9701CE084, 9703CE061 – 9703CE070, 9709CE416 – 9709CE425, 9903CM294 – 9903CM303, 9904CM400 – 9904CM409, 9909CM059 – 9909CM064, 9909CM156 – 9909CM169.

There are an additional 11 units with serial numbers that do not exist in the Olympus' old computer system (not available in BPCS).

REASON: Software malfunction.

MANUFACTURER: World of Medicine Gmbh Ludwigsstadt

RECALLED BY: Olympus America, Inc. (OAI) Melville, NY

DISTRIBUTION: Nationwide, and Brazil. 

QUANTITY: 88 units

 

PRODUCT AND CODE: Human Heart Valves, processed and frozen, for transplantation

Codes: Aortic valves, ID #98-0266HV-01 and ID #98-0271HV-01; Pulmonary Valve, ID #98-0266HV-02

REASON: Sera from donor of human tissues were tested with unapproved method.

MANUFACTURER/RECALLING FIRM: LIFENET VIRGINIA BEACH, VA

DISTRIBUTION: PA and NC

QUANTITY: 3 valves

 

PRODUCT AND CODE: lMx Glycated Hemoglobin Calibrators; list 1A86-01; an In Vitro diagnostic for calibration of the IMx Analyzer when used for the determination of Glycated Hemoglobin in human anticoagulated whole blood; each kit consists of 6 vials, Calibrators A - F, 0 -2.4 GHb; CODES:  List 1A86-01, Lots 68577M200 and 68577M201

REASON: Elevated Low Control values

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Nationwide and International

QUANTITY: 1925               

 

PRODUCT AND CODE: Steri-Oss HL Threaded Implant, HA-Coated 4.5D x 10mm, Endosseous Implant,

CODES:  Part Number 4610HL; Lot Number 321814

REASON: Label on cap does not match labels on inner and outer vials.

MANUFACTURER/RECALLING FIRM: Nobel BioCare USA, Inc. Yorba Linda, CA

DISTRIBUTION: Nationwide and Germany, Chile, Argentina, Korea, Hong Kong, Japan.

QUANTITY: 237

 

WEEK ENDING SEPTEMBER 22

 

FDA announces that eight U.S. firms that make hip implants are, or will be, voluntarily recalling certain of their hip implants due to a potential problem with a component. The component, a zirconia ceramic femoral head, was recalled by its French manufacturer St. Gobain Desmarquest August 14 because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. The component is the ball portion of the hip prosthesis that connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.

 

The French recall applies to nine batches of zirconia ceramic femoral heads manufactured since early 1998. The affected batches have the prefix "TH" before the batch number. All these potentially defective batches were manufactured after the beginning of 1998 when St. Gobain Desmarquest changed part of its manufacturing process. No metal or alumina femoral heads are involved in the recall.

 

U.S. companies estimate that hip implants with zirconia ceramic femoral heads are used in less than six percent of hip implant procedures in the United States. An estimated 150,000 to 200,0000 hip implants are performed annually in the United States. Surgeons should not continue to implant artificial hips with zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest since early 1998.

 

Patients who already have these hip implants should contact their surgeons with any questions or concerns. Not all zirconia ceramic femoral heads are expected to fail, and not all patients will experience a problem; therefore, FDA is not recommending surgery to replace hip implants that have not fractured or are not causing problems. Physicians will likely choose to monitor the performance of the implant more closely as a result of the potential program.

 

Fracture of implants with this component is usually signaled by a sudden pain in the implanted hip joint, sometimes preceded by an audible "pop" from the hip just before the onset of pain. If a hip implant fractures, surgery to replace it will be necessary.

No tests exist that can predict which patients will experience failure of their hip implants because of defective zirconia ceramic femoral heads.

The U.S. companies that use the St. Gobain Desmarquest zirconia femoral heads are: Apex Surgical, LLC, Lakeville, Mass.; Biomet, Inc., Warsaw, Ind.; DePuy Orthopaedics, Inc., Warsaw, Ind.; Encore Orthopedics, Inc., Austin, Tex.; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew, Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Inc., Warsaw, Ind.

 

PRODUCT AND CODE: Valleylab LigaSure vessel sealing system,

CODES: Catalog Number: LS1000, Lot ANH000503.

REASON: Previously recalled product, not released for distribution, was distributed.

MANUFACTURER/RECALLING FIRM: Valleylab, Inc., Boulder, CO

DISTRIBUTION: CA, CO, and PA.

QUANTITY: 18 units

 

PRODUCT AND CODE: Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

Codes: a) Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 through 2016

b) Model 4380221 - E.CAM Gantry Dual Head, serial numbers 0005 through 2038, and 31827

c) Model 5242826 - E.CAM Gantry Dual Head,serial numbers 1001 through 2012

REASON: Resistor Packs installed backward causes software errors.

MANUFACTURER/RECALLING FIRM: SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL

DISTRIBUTION: Nationwide and worldwide

QUANTITY: 229 units

 

PRODUCT AND CODE: Various sterile surgical convenience kits and trays, including biopsy,pacemaker, and cardiac catheterization procedural trays manufactured and labeled by AVID Medical, Inc., identified by catalog, lot number and date of manufacture on each product, and containing vialed injectables:

Ephedrine Sulfate 1 ml/50mg

Heparin Sodium, 10 ml vial

Heparin Injection 10 ml 1000 unit/ml

Heparin Lock 10 ml, 100 u/ml

Z Heparin Lock, 1 ml, 100 units

Lidocaine, 1% 30 mL MDV

Lidocaine, 50 mL 2% Vial M-Dose

Lidocaine 30 ml 2% Vial

Lidocaine, 30ml 1% VL Sng Dose

Lidocaine, 2%hcl 20 ml

Lidocaine, 50 ml 1% multidose

Lidocaine, 20 ml 1% multidose

Polocaine, 50 ml, 2% vial

Sensorcaine, .5% w/EPI 30 ml

Sodium Bicarbonate, 4%, 5ml VL

Sodium Chloride, 30 ml .9% vial

Sodium Chloride, 5cc vial

Codes:CAT # Lot # Kit Description

PLAS0001 #301893 Hair transplant

AV011303-02 #307827 Needle Core Breast Biopsy

AV011225 #306259,307312 Breast Pack

SUBE0007-01 #308133 Angio

SUBE0003 #308006 U.S/C.T. Biopsy

FOHF0010-02 #307711,307832 Biopsy Myelogram

FOHF0011-02 #307553,308271 Angio

MGHM0002 #306109,306644 Biopsy

NAVY001 #306554,307816 Cardiac Cath

SUBE0002 #303596 Breast Biopsy

AMBL0002 #307750 Vasectomy

AMBL0004 #307597 Vasectomy

SMHC0001 #307015,307658 Cardiac Cath

STMH0001-01 #306586,307891 Angio

MGHM0001 #307763 Angio

SMHC0005-01 #308245 Suture Tray

SMHC0004-01 #306815,307821 Angio

MINN0005-04 #307559, Angio

AC010928-01 #307275 E-P Tray

AV010929 #308036 Pacemaker

NAPO0035-01 #306481 AV Fistula

NAPO0036-01 #306482,307489           Carotid Endart

AV010913-01 #308024 Arthroscopy

VMCC0001 #306904,307594 Cardiac Cath

AV010767 #307051 Femoral

AV010992-02 #307795 Angio

TUCP0012-03 #307018 Neuro Angio

TUCP0020-03 #307975 Angio

TUCP0022-02 #307022,306475 Vascular

PMCP0002 #307543,307818 Special Angio

AV010892-01 #307394 Cardiac Cath

HOUS0030-02 #304837 Heart tray

MEDE0015 #307477 Cardiac Cath

Each containing one or more of following lot numbers of injectables:

VIAL INJECTABLE DESCRIPTION: ALL EXPIRY BETWEEN MAY 2001-SEP 2003

LIDOCAINE VIAL 30ML Lot 69-303-DK

LIDOCAINE 20ML VIAL Lot 63-249-DK, 69-03-DK, 52-572-DK

LIDOCAINE VIAL 30ML Lot 63-264-DK

EPHEDRINE SULFATE 1ML LOT 50-218-DK-01

LIDOCAINE VIAL 30ML+ LOT 59-275-DK-01, 61-061-DK-01, 59-220-

SODIUM BICARBONATE 5ML VL DK-01

SODIUM CHLORIDE VIAL 5CC LOT 9K003

SODIUM CHLORIDE VIAL 10CC LOT 66-394-DK

SODIUM CHLORIDE VIAL 10CC LOT 67-021-DK

SODIUM CHLORIDE VIAL 10CC LOT K150061

EPHEDRINE SULFATE 1ML LOT K150050

EPHEDRINE SULFATE 1ML LOT 46-349-DK

EPHEDRINE SULFATE 1ML LOT 46-349-DK-01

EPHEDRINE SULFATE 1ML LOT 64-510-DK-01

HEP SODIUM 10ML VIAL LOT 089138, 66-394-DK

LIDOCAINE VIAL 30ML LOT 65-364-DK

HEP SODIUM 10ML VIAL LOT 089138, 66-394-DK

LIDOCAINE 20ML VIAL+ LOT 50-298-DK, 58-691-DK, 58-465-DK

SODIUM CHLORIDE 30ML VIAL

LIDOCAINE 30ML VIAL LOT 040025

LIDOCAINE VIAL 30ML LOT 64-411-DK-01

LIDOCAINE 50ML VIAL LOT 65-290-DK-01

LIDOCAINE VIAL 30ML LOT 65-364-DK

LIDOCAINE 50ML VIAL LOT 59-113-DK

HEPARIN INJ 10ML VIAL LOT 030091

HEPARIN INJ 10ML VIAL LOT 030093

LIDOCAINE VIAL 30ML LOT 66-637-DK

LIDOCAINE VIAL 30ML LOT 66-636-DK

LIDOCAINE VIAL 30ML LOT 65186-DK01, 66636-DK01

LIDOCAINE 30ML 2% VIAL LOT 070128

LIDOCAINE VIAL 30ML LOT 66-636-DK-01, 64-568-DK-01

LIDOCAINE 50ML VIAL LOT 68-690-DK01, 68-690-DK02

LIDOCAINE VIAL 30ML LOT 65-061-DK, 65-364-DK

LIDOCAINE 30ML 2% VIAL LOT 040150

LIDOCAINE VIAL 30ML LOT 66-636-DK,66-673-DK

POLOCAINE 50ML VIAL+ LOT 001098,030119,119035

HEP LOCK 10ML

SODIUM BICARBONATE 5ML VL LOT 67-129-DK-01

LIDOCAINE 20ML VIAL LOT 68-364-DK,61-046-DK,LOT 67-027-DK-01

LIDOCAINE 50ML VIAL LOT 69-201-DK01

LIDOCAINE 50ML VIAL LOT 66-506-DK

SODIUM BICARBONATE 5ML VL+ LOT 67-129-DK-01

SODIUM CHLORIDE 10ML VIAL LOT 65-230-DK

LIDOCAINE VIAL 30ML LOT 66-636-DK,68-567-DK

LIDOCAINE 20ML VIAL LOT 69-233-DK-01

LIDOCAINE VIAL 30ML LOT 68-583-DK

HEPARIN INJ 10ML VIAL LOT 080082

LIDOCAINE 50ML VIAL LOT 69-201-DK, 63-157-DK

LIDOCAINE VIAL 30ML LOT 68-657-DK-01, 68-867-DK-01, 66-636-DK-01

LIDOCAINE 30ML 2% VIAL LOT 070128, 080184

LIDOCAINE 20ML VIAL+ LOT 69-048-DK

SODIUM BICARBONATE 5ML VL LOT 67-129-DK

LIDOCAINE 50ML VIAL LOT 68-690-DK-01, 69-203-DK-02

LIDOCAINE 20ML VIAL LOT 69-233-DK

LIDOCAINE 20ML VIAL LOT 69-233-DK-01

LIDOCAINE 30ML 2% VIAL LOT 070128

LIDOCAINE 30ML 2% VIAL LOT 040150

LIDOCAINE VIAL 30ML LOT 69-303-DK, 68-583-DK

HEPARIN LOCK 1ML LOT 050147

SENSORCAINE 30ML VIAL LOT 004031

LIDOCAINE 50ML VIAL LOT 68-690-DK

SODIUM BICARBONATE 5ML VL LOT 69-258-DK-01,67-129-DK-01

LIDOCAINE VIAL 30ML LOT 69-303-DK

SODIUM BICARBONATE 5ML VL+ LOT 61-044-DK-01

SODIUM CHLORIDE 10ML VIAL

LIDOCAINE 50ML VIAL LOT 69-159-DK

LIDOCAINE 50ML VIAL LOT 69-265-DK-01, LOT 69-338-DK-01

LIDOCAINE VIAL 30ML LOT 69-293-DK

REASON: Stability and potency of kit injectable components cannot be assured after sterilization

MANUFACTURER/RECALLING FIRM: Avid Medical, Inc., Toano, VA

DISTRIBUTION: Nationwide

QUANTITY: 3408 kits and/or trays

 

PRODUCT AND CODE: BVS 5000i Bi-Ventricular Support ConsoleS/N's: 1599, 1601, 1602, 1609, 1611-1646

Codes: BVS 5000i Bi-Ventricular Support Console S/N's: 1599, 1601, 1602, 1609, 1611-1646

REASON: Leaking Compressor gaskets may cause low flow

MANUFACTURER/RECALLING FIRM: Abiomed, Inc., Danvers, MA.

DISTRIBUTION: Nationwide; Foreign: Australia, Netherlands,(Hospital Laval, Quebec) Canada, Spain, Mexico

QUANTITY: 40

 

PRODUCT AND CODE: CryoValve Allograft (Heart Valve) Codes: Model AV00 - Serial Number 3936694

Model PV00 - Serial Number 3936708

REASON: Does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER/RECALLING FIRM: CRYOLIFE, INC. KENNESAW, GA

DISTRIBUTION: NC and OK

QUANTITY: 2 values

 

PRODUCT AND CODE: Olympic Medical Vac Pac - primarily used to assist in maintaining patient position during surgery.

Codes: Catalog #51630, size 30, serial #s 69862 through 70114 Catalog #51635, size 35, serial #s 69787 through 69830

REASON: Weak Seam Seal - Product not remaining firm as intended.

MANUFACTURER/RECALLING FIRM: OLYMPIC MEDICAL CORP. SEATTLE, WA

DISTRIBUTION: Nationwide and Canada, Ireland, Korea, New Zealand, Thailand, The Netherlands, United Kingdom and Germany

QUANTITY: Catalog #51630 - 209; Catalog #51635 - 33

 

PRODUCT AND CODE: Roche/Hitachi Modular P Laboratory Clinical Chemistry Analyzer,Catalog No. 766-4019, All Serial Numbers;

REASON: Incorrect results are obtained if the wash rack is placed on the instrument before placing the instrument in standby or stop mode.

MANUFACTURER/RECALLING FIRM: Roche Diagnostics Corp., Indianapolis, IN

DISTRIBUTION: Nationwide

QUANTITY: 150

 

PRODUCT AND CODE: Intravenous Administration Sets for use with Gemstar infusion pumps.

13009-01 Latex-Free GemStar Pump Set-SL, Non-Vented, 110 " (w/ Yellow Striped Tubing)

13012-01 GemStar Pump Set with 0.2 Micron Filter, LIFESHIELD Prepierced Reseal Y Site, Non-Vented, 96 Inch- SL

13013-01 GemStar Nonphthalate Pump Set with 1.2 Micron, Filter, LIFESHIELD Prepierced Reseal Y Site Nonvented, 96"-SL

13014-01 GemStar Primary Pump Piggyback Set, with Convertible Piercing Pin, 110 inch with Backcheck Injection Site, Prepierced/Prepierced Y-Injection Site SL

13015-01 LifeShield Latex-Free GemStar Pump Set-SL, Nonvented, 96 inch (with Orange Polyethylene-lined resistant Tubing)

13016-01 Latex-Free GemStar I.V. Pump Set w/ PCA Extension-SL, Nonvented, 110 inch

13030-01 GemStar HEMA II Y-Type Blood Pump Set

13042-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set - SL, Convertible Pin, 110 inch

13043-01 GemStar Primary Pump Set

13044-01 GemStar Pump I.V. Set

13046-01 Latex-Free GemStar Pump Set-SL, Nonvented, 96 inches

13242-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set-OL, Convertible Pin, 110 inch with 3 Clave Ports

13243-01 LifeShield Latex-Free GemStar Piggyback Pump Set- OL, Convertible Pin, 110 inch with 0.2 Micron Filter and 3 Claves

13245-01 LifeShield Latex-Free GemStar Primary Piggyback Pump Set - OL, Convertible Pin, 110 inch with 2 Claves

Codes:

List No. 13009-01; Lots 45307HG, 70011HG, 75084HG, 77070HG, 78090HG

List No. 13012-01; Lots 79099HG, 75105HG, 73141HG, 70136HG, 68165HG, 45295HG

List No. 13013-01; Lots 76068HG, 75088HG, 73151HG, 70224HG, 68144HG, 46256HG

List No. 13014-01; Lots 68148HG, 60303HG, 47205HG, 43289HG, 75094HG

List No. 13015-01; Lots 69172HG, 48246HG, 74076HG

List No. 13016-01; Lots 45308HG, 77158HG

List No. 13030-01; Lots 63127HG, 70268HG, 75061HG

List No. 13042-01; Lots 70107HG, 63107HG

List No. 13043-01; Lots 68247HG, 74070HG, 78120HG

List No. 13044-01; Lots 70226HG, 68229HG

List No. 13242-01; Lot 76211HG

List No. 13243-01; Lot 77262HG

List No. 13245-01; Lots 78233HG, 77263HG

List No. 13046-01; Lots 75108HG, 76140HG, 73146HG, 70204HG, 71117HG, 53128HG, 50352HG, 67212HG

REASON: Sets over infuse with user error during setup

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Laurinburg, NC

RECALLED BY: Abbott Laboratories, Inc. San Diego, CA

DISTRIBUTION: Nationwide and to United Kingdom, France, Canada, Australia

QUANTITY: 89,468

 

PRODUCT AND CODE: AxSYM Troponin-I; a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of acute myocardial infarction (AMI). Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Codes: Reagent Lots - list 3C29-20; lots 69644M300, 69644M301, 70246M300, 70246M301, 70974M300, 70974M301, 71096M200, 71096M201, 71112M200, 71112M201, 71113M200, 71113M201, 71115M200, 71115M201, 71214M100, 71214M101, 71215M100, 71215M101

Calibrator Lots - list 3C29-01: Lots 70525M100, 70525M101, 70525M102.

REASON: Falsely high results

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Nationwide, and International

QUANTITY: 35523 -reagent, 3241 -calibrator

 

PRODUCT AND CODE: Disposable Glass Tip (P/N 10,010,142), a single use component used with Dermabrader DMS1000 handpiece, for scar revision and tattoo removal. Instrument is classified as a Dermatome, class I device. Disposable tips packaged in cartons, 24 pieces/carton. Codes: Lots 637, 691, 11, and 39

REASON: Burr on plastic tip of dermabrasion instrument could cause injury to skin.

MANUFACTURER/RECALLING FIRM: Mattioli Engineering Corporation, SRA, Firenze Italy.

RECALLED BY: Mattioli Engineering Corporation, Arlington, VA

DISTRIBUTION: CA, SC, FL, NY, TX, and CO, and Canada

QUANTITY: 3032 pieces

 

PRODUCT AND CODE: Steris Quick Connect, Model C1665, is designed to process the Olympus 20D Series and BF-XT20 Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160 Universal Processing Tray.

Codes: Lot Number: CA22900. Catalogue Number: #QC 1665.

REASON: The tubing in the kits are labeled with an incorrect endoscope model number.

MANUFACTURER/RECALLING FIRM: STERIS CORP. MENTOR, OH

DISTRIBUTION: GA

QUANTITY: 2 units

 

WEEK ENDING SEPTEMBER 29

 

PRODUCT AND CODE:

Abbott Cell-Dyn 3200 CS

Abbott Cell-Dyn 3200 SL

Abbott Cell-Dyn 3200 systems manufactured after

06/23/00 that contain 486-microprocessing chips.

List No./Serial Number:

Abbott Cell-Dyn 3200 CS 04H59-01

Includes Serial Numbers 29983AH-29993AH

Abbott Cell-Dyn 3200 SL 04H60-01

Includes Serial Numbers 60873AF-60906AF

CODES:  List No./Serial Number:

Abbott Cell-Dyn 3200 CS 04H59-01

Includes Serial Numbers 29983AH-29993AH

Abbott Cell-Dyn 3200 SL 04H60-01

Includes Serial Numbers 60873AF-60906AF

REASON: Analyzers may exhibit fluctuation in hematology results under certain parameters

MANUFACTURER: Abbott Diagnostics Division Santa Clara, CA

RECALLED BY: Abbott Laboratories, Inc. Santa Clara, CA

DISTRIBUTION: Nationwide

QUANTITY: 45 units

 

PRODUCT AND CODE: Architect Free T3 Controls, list 06C48-10; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; The kit contains 3 bottles (8mL each) of T3 in human serum at the following levels: L = 3.1, M = 6.0, and H = 10.5 pg/mL.

Codes:List 06C48-10, lot 62967M300

REASON: High Control concentrations read below package insert specifications

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Nationwide, and England, Japan, Hong Kong, Korea, New Zealand, Australia, Canada and Singapore.

QUANTITY: 610 units

 

PRODUCT AND CODE: Pulstar Anti-Embolism Wrap, Codes: Model number Lot Nos. B51558-01, 200194, 200211, 200290, 51558-01, 200218, 200326, 200339, 200346, 201004      

REASON: Tearing at the sewn seam of an anti embolism wrap (compression sleeve)

MANUFACTURER/RECALLING FIRM: Alba-Waldensian, Inc. Rockwood, TN

DISTRIBUTION: Nationwide

QUANTITY: 8258 units

 

PRODUCT AND CODE: Adapta MC-100 Massage Chair Codes: Serial Number 1000-1074, manufactured on 9/15/00

REASON: Massage chair frames break under the weight of massage clients

MANUFACTURER: Master Home Products Morton Grove, IL

RECALLED BY: Chattanooga Group, Inc. Hixton, TN

DISTRIBUTION: CA, TN, TX, OK, NV, MA and Mexico, South Africa, and Venezuela

QUANTITY: 53 units

 

PRODUCT AND CODE: Pentax brand Video Colonoscopes and Fiber Colonoscopes.  The Angle Wire Receptacle component is the affected part. Codes: Video Colonoscopes (510k Model

Affected Model #         Reference #)             

EC-3430FK                 (EC-3800L)

EC-3430L                  (EC-3800L)

EC-3430LK                 (EC-3800L)

EC-3440L                  (EC-3840L)                        

EC-3801L                  (EC-3800L)

EC-3830LK                 (EC-3800L)

EC-3830LZ                 (EC-3800L)

EC-3830TL                 (EC-3800TL)

EC-3830TLK                (EC-3800TL)

EC-3831L                  (EC-3800L)

EC-3840TL                 (ORIGINAL)

EC-3400F                  (EC-3800L)

EC-3400L                  (EC-3800L)

EC-3800L                  (ORIGINAL)

EC-3800TL                 (ORIGINAL)

EC-3801F                  (EC-3800L)

EC-381L30                 (EC-3800L)

EC-3830L                  (EC-3800L)

EC-3840L                  (ORIGINAL)

EC-38TL30                 (EC-3800TL)

Fiber Colonoscopes        (510k Model

Affected Model #          Reference #)             

FC-34FX                   (FC-38LX)

FC-34LX                   (FC-38LX)

FC-38FH                   (FC-38LH)

FC-38LH                   (ORIGINAL)

FC-38LP                   (FC-38LH)

FC-38LX                   (ORIGINAL)

FC-38LV                   (FC-38LX)

FC-38SX2                  (FC-38LX)

There are 6 Operator Manuals that support the affected models: Z171 R04, Z207 R04, Z231 R05, Z237 R06, Z242 R05, Z270 R01.

Affected Serial Numbers: There are 3019 serial numbers for the distributed units.  Please contact CDRH, Pentax or NYK-DO's Recall

Coordinator (Downstate) for the serial numbers being recalled.

REASON: Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down).

MANUFACTURER: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan

RECALLED BY: Pentax Precision Instrument Corporation (PPIC) Orangeburg, NY

DISTRIBUTION: Nationwide and International

QUANTITY: 3019 units                     

 

PRODUCT AND CODE: Gemini Hip Stem, Catalog Nos. 1374-12-000 and 1374-13-000

Codes: 1.  Gemini hip stem, catalgo # 1374-12-000, lot S55H61. 2.  Gemini hip stem, catalog # 1374-13-000, lot S5WHB1.

REASON: Incorrect size number etched into hip stems

MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc. Warsaw, IN

DISTRIBUTION: MS, OH, and Canada

QUANTITY: 10 units

 

PRODUCT AND CODE: LCS Total Knee Meniscal Bearing Tibial insert.

Codes: 1.  LCS total knee meniscal bearing tibial insert, STD, 15 mm.  Catalog # 1178-22-025.  Lot UF9JH1.

2.  LCS total knee meniscal bridging tibial inser, STD+/LG, 12.5 mm. catalog # 1278-25-025.  Lot UH3PX1.

REASON: Outer boxes labeled with incorrect product code and description

MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc. Warsaw, IN

DISTRIBUTION: Germany and Korea

QUANTITY: 15 units

 

PRODUCT AND CODE: Roche/Hitachi 917 Rack System connected to CLAS. Codes: Roche/Hitachi 917 Rack System connected to CLAS, Catalog number 917100.  All systems connected to a CLAS system.

REASON: Potential sample/results mismatch

MANUFACTURER: Hitachi Instruments Division Iari-ken, Japan

RECALLED BY: Roche Diagnostics Corp. Indianapolis, IN

DISTRIBUTION: IN, NY, SC and TX

QUANTITY: 5 units

 

PRODUCT AND CODE: Split Tissue Protection Sleeve Codes: Product Number 393.745 Lot number 4041562 and Product Number 393-746 Lot number 4044728.

REASON: Mislabeled protection sleeves

MANUFACTURER: Synthes (USA) West Chester, PA

RECALLED BY: Synthes (USA) Paoli, PA

DISTRIBUTION: Nationwide

QUANTITY: 24 units

 

PRODUCT AND CODE: Save-A-Tooth Emergency Tooth Preserving System. The product is shipped in cases of 24 units. A unit is a complete preserving system.  The unit is a plastic jar filled with preserving solution. Codes: catalog number Z-12488-1, part number 32-393,

lot number 512844

REASON: Product leaking, compromising sterility.

MANUFACTURER/RECALLING FIRM: Polysciences, Inc. Warrington, PA

RECALLED BY: Save-A-Tooth, Inc. Pottstown, PA

DISTRIBUTION: AZ

QUANTITY: 417 cases

 

PRODUCT AND CODE: IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86-88; the set is composed of the IMx Gylcated Hemoglobin Ion Capture Reagent Pack, list 1A86-20, which contains 1 bottle (10.5 mL) Polyanion Affinity Reagent, 1 bottle (11.1 mL) Lysis Reagent, 1 bottle (10.5 mL) Sorbitol in buffer and 1 bottle (28.0 mL) Wash Buffer, and 1 box (100) Ion Capture Reaction Cells, list 5A57-01; Abbott Laboratories Codes: List 1A86-88, lot numbers 75755M300 and 75779M300

REASON: Imprecise results (low) on patient specimens

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Nationwide, and International

QUANTITY: 4490 kits                        

 

PRODUCT AND CODE: Freedom60 Tubing Set, 2 mL per hour Intended for use with Freedom60 Syringe Infusion Pump System

Individual packaged and sterilized.  Sold in boxes of 50. Codes: Lot Number: 1.300/00 Catalog Number: F2ML

REASON: Separation of the female luer connector.

MANUFACTURER/RECALLING FIRM: Repro-Med Systems, Inc. Chester, NY

DISTRIBUTION: CA, PR, OH, KS and TX

QUANTITY: 311 units

 

PRODUCT AND CODE: Sensation Plus Lubricated and Sensation Plus Spermicidal Lubricant, Codes: Product No. Sensation Plus Lubricated:  Lot Nos. 0007900889, (Exp 07/2003), 03/99/C (Exp 02/2002), and 02/00/A (Exp 01/2003)

REASON: Retail packaging error, condoms were packaged into wrong retail boxes

MANUFACTURER: Ansell Healthcare Products, Inc. Dothan, AL

RECALLED BY: Ansell Healthcare Products, Inc., Cowansville, QE

DISTRIBUTION: Canada

QUANTITY: 1923 units

 

PRODUCT AND CODE: X-SYSTEMS Methadone Controls, list 09676-10; an in-vitro diagnostic used for the verification of calibration of the TDxFLx, TDx or ADx System when used for the semi-quantitative determination of methadone in human urine.  Distributed in Europe by Abbott, Germany Codes: List #09676-10, lot 76062Q200, exp. 3/3/02

REASON: Methadone Controls manufactured at methadone concentrations below target value

MANUFACTURER: Abbott Health Products, Inc. Barceloneta, PR

RECALLED BY: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Germany, Hong Kong and Australia

QUANTITY: 19 kits

 

PRODUCT AND CODE: X-SYSTEMS Multiconstituent Controls for Abused Drug Assays, list 09687-12; an in-vitro diagnostic used for the verification of calibration of the Abused Drug assays on the AxSYM, TDxFLx, TDx or ADx systems. Distributed in Europe by Abbott, Germany Codes: List #09687-12, lots 72409M100, exp. 10/31/01, and 74338M300, exp. 11/30/01.

REASON: Methadone Controls manufactured at methadone concentrations below target value

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Nationwide and International.

QUANTITY: 1446 kits.