DECEMBER 2001

WEEK ENDING DECEMBER 1

 

PRODUCT Radiation Treatment Planning Decision Support System (DSS)

CODE All versions.

RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO

REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. 

VOLUME OF PRODUCT IN COMMERCE 320.

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT Replace (brand), Easy Abutment, 5.5mmH, 0.5mm MARGIN, 4.3mm SERIES (SELECT)

CODE Part Number: 61641; Lot Number: 320130, 320150, 320151, 320403, 320404, 320405, 320926.

Part Number: 61642; Lot Number: 320161, 320162, 320406, 320407, 320482.

Part Number: 61643; Lot Number: 320163, 320408, 321748.

Part Number: 61644; Lot Number: 320164, 320409, 321749.

Part Number: 61645; Lot Number: 320172, 320174, 320927, 320928, 322079, 322664.

Part Number: 61646; Lot Number: 320179, 320929, 320930, 322080, 322668.

Part Number: 61647; Lot Number: 320180, 320931, 321750, 322081, 322669.

Part Number: 61648; Lot Number: 320181, 321752, 333082, 322672.

Part Number: 61649; Lot Number: 320182, 321440, 322083.

Part Number: 61650; Lot Number: 320183, 321325, 322084.

Part Number: 61651; Lot Number: 320184, 321441.

Part Number: 61652; Lot Number: 320185, 321442.

Part Number: 61656; Lot Number: 321679, 326218.

Part Number: 61657; Lot Number: 321680, 324398, 326342.

Part Number: 61658; Lot Number: 321681.

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

REASON Poor rework instructions caused mix of sterile and nonsterile components.

VOLUME OF PRODUCT IN COMMERCE 2,952

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT a) LifeSite Hemodialysis Access System; b) LifeSite Hemodialysis Cannula Exchange Kit

CODES a) LifeSite Hemodialysis Access System, Catalog # LHAS14120, Lot Numbers: ADH0013, ADH0015, ADH0020, ADI001, ADI002, ADI0007, ADI0008,ADJ0009, ADJ0016, ADJ0017, ADJ0018, ADJ0019, ADJ0020, ADJ0021, ADK0017, ADK0018; 83, 85 TO 91; 258 TO

261; 11057 AND 11058. b)  LifeSite Hemodialysis Cannula Exchange Kit, Model LHCEK0000, Lot Numbers: 99;100;406;407;408 and 409.

RECALLING FIRM/MANUFACTURER Vasca Inc., Tewksbury, MA

REASON Labeling Change to Instructions for use in Heparin Lock Concentration.

VOLUME OF PRODUCT IN COMMERCE a) 2,262 units; b) 658 units. 

DISTRIBUTION Nationwide.

 

PRODUCT Storz Opthalmics Concentrix Phaco Pack Sterile

CODE Lot number S7831.

RECALLING FIRM/MANUFACTURER Recalling Firm: Bausch & Lomb St. Louis, MO

Manufacturer: Bausch & Lomb Surgical Clearwater, FL

REASON The irrigated line tubing may not properly adhere to the product's cassette.

VOLUME OF PRODUCT IN COMMERCE 870 units (145 boxes of 6 units per box).

DISTRIBUTION Nationwide and Bausch & Lomb facilities in China; Australia, Canada, Japan, and Mexico.

 

PRODUCT CryoValve Allograft (Heart Valve)

CODE a) Model No. AV00 - Serial Number 6170625; b) Model No. PV00 - Serial Number 6173071.

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

REASON Donor does not meet current guidelines regarding serodilution of plasma.

VOLUME OF PRODUCT IN COMMERCE 2 valves.

DISTRIBUTION MD and CA.

 

PRODUCT CryoValve Allograft

CODE Model PV10 - Serial Number 6132081.

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

REASON Donor does not meet current guidelines regarding serodilution of plasma.

VOLUME OF PRODUCT IN COMMERCE 1 valve.

DISTRIBUTION WI.

 

PRODUCT CryoValve Allograft

CODE Model AV00 - Serial Number 6173837.

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

REASON Donor does not meet current guidelines regarding serodilution of plasma

VOLUME OF PRODUCT IN COMMERCE 1 valve.

DISTRIBUTION NC.

 

PRODUCT CryoValve Allograft

CODE Model Number PV00 - Serial Number 6173845.

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

REASON Donor does not meet current guidelines regarding serodilution of plasma

VOLUME OF PRODUCT IN COMMERCE 1 valve.

DISTRIBUTION PA.

 

PRODUCT CryoValve Allograft

CODE Model Number AV00 - Serial Number 6132073.

RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, Ga

REASON Donor does not meet current guidelines regarding serodilution of plasma

VOLUME OF PRODUCT IN COMMERCE 1 valve.

DISTRIBUTION CA.

 

PRODUCT Arcoskop Ceiling Mounted Image Intensifier System

CODE Model Number 4774019, Serial Numbers 01019, 01017, 01015, 01002.

RECALLING FIRM/MANUFACTURER Manufacturer: Siemens AG D-91025 Erlangen, Germany, 

Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ

REASON The C-arm separated from the swivel arm and fell.

VOLUME OF PRODUCT IN COMMERCE 4 devices.

DISTRIBUTION FL, NJ, TX, WI, and Germany.

 

PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing of  both large and small molecular weight analytes

CODE Software versions 3.00, 3.01, 3.03, 3.04a, 3.60, 4.00.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX

REASON The system may report sample results from the incorrect sample tube.

VOLUME OF PRODUCT IN COMMERCE 17,508.

DISTRIBUTION Nationwide and world wide.

                 

PRODUCT Remel Mueller Hinton Agar

CODE Product No. 01620 packaged 10 plates/pkg, Lot No. 189356.

RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS

REASON Some plates in the lot were contaminated with Staphylococcus aureus.

VOLUME OF PRODUCT IN COMMERCE  2,420 plates.

DISTRIBUTION Nationwide.            

 

WEEK ENDING DECEMBER 8

 

PRODUCT Adult and Pediatric Heated Wire Breathing Circuits:

CODE a) Adult Heated Wire Breathing Circuits:780-19;780-20;780-31;780-32;780-33; 780-34;780-35;780-36;780-51;780-52;790-32;790-52.

b) Pediatric Heated Wire Breathing Circuits:780-23;780-24;780-25;780-30.

RECALLING FIRM/MANUFACTURER Hudson Respiratory Care, Inc., Temecula, CA

REASON Risk of overheating and fire.

VOLUME OF PRODUCT IN COMMERCE 892,772.

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT AEROSET (brand) Uric Acid, product list number, part or model: LN 07D76-01. All lots (inclusive lot numbers detailed later)

CODE All lots and codes of Uric Acid for use in Aeroset brand. 67058HW00;64093HW00;69086HW00;66056HW00;76043HW00;79015HW00.

RECALLING FIRM/MANUFACTURER Abbott laboratories, Inc., South Pasadena, CA

REASON Discoloration -- calibration must be done with cartridge change.

VOLUME OF PRODUCT IN COMMERCE 1,545.

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT Brand Name: BD 3ml Syringe with BD Twinpak, BD 10ml Syringe with BD Twinpak. 

Common Name: Piston syringe with blunt plastic cannula and metal Cannula

CODE Catalog No.  303391 and 303393, Lot Numbers: 1149658, 1198494 and 1127987.

RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & CO., Franklin Lakes, NJ

Manufacturer: Becton Dickinson Consumer Products, Holdredge, NE.

REASON Improperly sealed unit packages

VOLUME OF PRODUCT IN COMMERCE 1,023,000 units.

DISTRIBUTION Nationwide.

 

PRODUCT a) AEROSET Aspartate Aminiotransferase (AST) Part Number LN 07D81-01 b) AEROSET Alanine Aminotransferase (ALT) Part number LN 07D56-01

CODE All products, Aeroset Clinical Chemistry Analyzer.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA

REASON Failure to exhibit Linear Low Flag upon substrate depletion condition.

VOLUME OF PRODUCT IN COMMERCE 493.

DISTRIBUTION Nationwide and worldwide.

 

WEEK ENDING DECEMBER 15

 

PRODUCT Femoral Heads,

CODE: B. Howmedica„Zirconia Femoral Head (K920577 and K946026),

Product Numbers  Product Description      MFG Date or Last Date

6284-3-126             Zirconia Head 26mm STD   *

6284-3-128             Zirconia Head 28mm STD   Sept 1998

6284-3-132             Zirconia Head 32mm STD   March 1995

6284-3-226             Zirconia Head 26mm,+5mm  *

6284-3-228             Zirconia Head 28mm,+5mm  Feb 1996

6284-3-232             Zirconia Head 32mm,+5mm  March 1995

C. V40 Zirconia Femoral Heads (K952418) include:

                (5-year expiration from date of manufacture)                                                         

Product Numbers  Product Description       MFG Date or Last Date  

 6264-6-028     V40 Zirconia Fem Head 28mm,-4mm  *

 6264-6-122     V40 Zirconia Fem Head 22mm STD   *

 6264-6-128     V40 Zirconia Fem Head 28mm STD   August 1997

 6264-6-222     V40 Zirconia Fem Head 22mm,+3mm  *

 6264-6-228     V40 Zirconia Fem Head 28mm,+4mm  August 1997

6264-6-328     V40 Zirconia Fem Head 28mm,+8mm  *

 6264-6-428     V40 Zirconia Fem Head 28mm,+12mm *

B. Howmedica„µ Zirconia Femoral Head (K920577 and K946026) include:

(5-year expiration from date of manufacture)

Product Numbers   Product Description      MFG Date or Last Date

 6284-3-126      Zirconia Head 26mm STD   *

 6284-3-128      Zirconia Head 28mm STD   Sept 1998

 6284-3-132      Zirconia Head 32mm STD   March 1995

 6284-3-226      Zirconia Head 26mm,+5mm  *

 6284-3-228      Zirconia Head 28mm,+5mm  Feb 1996

 6284-3-232      Zirconia Head 32mm,+5mm  March 1995

C. V40 Zirconia Femoral Heads (K952418) include:

                (5-year expiration from date of manufacture)                                                      

Product Numbers  Product Description     MFG Date or Last Date  

 6264-6-028    V40 Zirconia Fem Head 28mm,-4mm  *

 6264-6-122    V40 Zirconia Fem Head 22mm STD   *

 6264-6-128    V40 Zirconia Fem Head 28mm STD   August 1997

 6264-6-222    V40 Zirconia Fem Head 22mm,+3mm  *

 6264-6-228    V40 Zirconia Fem Head 28mm,+4mm  August 1997

 6264-6-328    V40 Zirconia Fem Head 28mm,+8mm  *

 6264-6-428    V40 Zirconia Fem Head 28mm,+12mm *

RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Allendale, Corp., NJ

Manufacturer: Morgan Matroc Ltd., Rugby, Warwichshire, United Kingdom, CV213Q.

REASON Potential breakage of ceramic femoral heads.

VOLUME OF PRODUCT IN COMMERCE 271 units.

DISTRIBUTION Nationwide

 

PRODUCT All GEM Analyzers including: a) GEM 6 Plus Model 2300; b) GEM Premier Model 5300; c) GEM Stat Model 4300; d) GEM Premier Plus Model 5500; e) GEM Premier 3000 Model 5700.

CODE: All codes.

RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory Co., Lexington, MA

Manufacturer:  Instrumentation Laboratory Co., Orangeburg, NY. 

REASON Thiopental sodium, an anesthetic agent, may interfere with Na+, K+ and Cl- reading.

VOLUME OF PRODUCT IN COMMERCE 1,997.

DISTRIBUTION Nationwide.

 

PRODUCT Roche Elecsys Model 1010 Analyzers, Catalog # 1705253

CODE All units.

RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnoistics Corp., Indianapolis, IN

Manufacturer:  Tegimenta RD Instrument Center Switzerland. 

REASON Electrical short may cause fire in the sample incubation chamber.

VOLUME OF PRODUCT IN COMMERCE 223 units.

DISTRIBUTION Nationwide.

 

PRODUCT CryoValve Allograft,  a) Model Number AV00; b) Model Number PV00.

CODE a) Serial Number 6010989; b) Serial Number 6010997.

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

REASON Donor did not meet current guidelines regarding serodilution of plasma.

VOLUME OF PRODUCT IN COMMERCE 2 valves.

DISTRIBUTION LA and Canada.

 

PRODUCT CryoValve Allograft, a) Model Number AV00; b) Model Number PV00.

CODE a) Serial Number 6964281; b) Serial Number 6964303.

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

REASON Donor did not meet current guidelines regarding serodilution of plasma.

VOLUME OF PRODUCT IN COMMERCE 2 items.

DISTRIBUTION PA.

 

WEEK ENDING DECEMBER 22

 

PRODUCT a) TDx/TDxFlx Ethanol Reagent; b) ADx Ethanol Reagent

CODEa) List no.   9545-60

Lot nos.      Exp. Date

72250Q100     7/30/01;

75440Q100     10/5/01;

75528Q100     10/17/01;

76478Q100     11/22/01.

b) List No.   9545-55

Lot no.       Exp. Date  

72259Q100     7/23/01;

72727Q100     9/9/01;

75532Q100     10/12/01;

76474Q100     11/11/01.

RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc. Barceloneta, Puerto Rico

REASON Calibration curve failure.

VOLUME OF PRODUCT IN COMMERCE 5,600 units.

DISTRIBUTION Worldwide.

 

PRODUCT A sterile dressing, labeled in part: "SURGIPAD* Combine Dressing DRESSING 8 in x 7.5 in. 

CODE Product Code is 2144 and can be found in the lower right corner of the front label face as "REORDER 2144".

Lot Numbers (found in the upper right corner of front of the package):

2001 07 1 01; 2001 07 2 01; 2001 07 3 01; 2001 08 1 01; 2001 08 2 01; 2001 08 3 01.

RECALLING FIRM/MANUFACTURER  Recalling Firm: Johnson & Johnson Medical, Div. of Ethicon, Inc. Arlington, TX

Manufacturer: Johnson & Johnson Medical, Div. of Ethicon, Inc. Sherman, TX

REASON Seal Integrity - possibly non-sterile device.

VOLUME OF PRODUCT IN COMMERCE 751,680.

DISTRIBUTION Nationwide.

 

PRODUCT Medi-tech TSK Surecut Biopsy Needle (Sterile)

CODE

Catalog # Product         UPN/Material#   Lot#    EXP.Date

40-812     SURECUT/15/70   M001408120           6157       04/2001  

40-815     SURECUT/15/120 M001408150            6167      04/2001  

40-823     SURECUT/16/90   M001408230            6118      03/2001  

40-823     SURECUT/16/90   M001408230            6157      04/2001  

40-834     SURECUT/17/100 M001408340            6167      04/2001  

40-834     SURECUT/17/100 M001408340            6234      05/2001  

40-843     SURECUT/18/90   M001408430            6157      04/2001  

40-843     SURECUT/18/90   M001408430            6234      05/2001  

40-855     SURECUT/19/120 M001408550            6118      03/2001  

40-865     SURECUT/21/120 M001408650            6118      03/2001  

40-865     SURECUT/21/120 M001408650            6167      04/2001  

40-873     SURECUT/22/90   M001408730            6118      03/2001  

40-873     SURECUT/22/90   M001408730            6167      04/2001  

40-894     SURECUT/25/100 M001408940            6054      02/2001  

RECALLING FIRM/MANUFACTURER Recalling Firm:  Med I-Tec, a division of Boston Scientific Corp., Watertown, MA

Manufacturer:  TSK Laboratory Japan, Tochigi-Ken, Japan.

REASON Expired sterile product was distributed.

VOLUME OF PRODUCT IN COMMERCE 167 Units.

DISTRIBUTION Nationwide

 

PRODUCT Allegiance Custom Sterile Procedure Kits; labeled as containing either one or two size 7.5 powdered synthetic surgical gloves and may or may not have a warning labeled "Caution: This product contains natural rubber latex which may cause allergic reactions.

CODE

a) Cat. SAN31ANELA, lot/order #497768, exp. 3/01/03

b) Cat. SMA31VGWLG, lot/order #501204, exp. 12/01/01

c) Cat. SER33OBCDC, lot/order #498994, exp. 5/01/03

d) Cat. SCV32AVMDC, lot/order #496157

e) Cat. SBA34BAMGA, lot/order #499993

f) Cat. SOP34ARMGG, lot/order #496681

g) Cat. SLC34LPMGF, lot/order #506220, exp. 6/01/03

h) Cat. SOP34KNBMM, lot/order #499947, exp. 3/31/03

i) Cat. SBA40ABPLF, lot/order #493477, exp. 3/01/03

RECALLING FIRM/MANUFACTURER Recalling Firm:   Allegiance Healthcare Corporation McGaw Park, IL

Manufacturer:  Allegiance Healthcare Corporation, Custom Sterile Division McGaw Park, IL

REASON Custom Sterile Kits contain Latex Gloves not declared on label.

VOLUME OF PRODUCT IN COMMERCE 897 kits

DISTRIBUTION OH, MN, IL, MI, and Canada

 

PRODUCT a) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump

Primary ADDitIV IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Intelligent Pump

Primary ADDitIV IV Sets, Clave Intelligent Pump IV Sets, Baxter Compatible Pump IV Sets with SafeLine, Baxter Compatible Pump IV Sets

with Clave, Baxter Compatible Pump Primary ADDitIV IV Sets, SafeLine Primary ADDitIV IV Sets, and Clave Primary ADDitIV IV Sets.  Common Name: Intravascular Administration Set.

b) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump Primary ADDitIV IV Sets, Ultrasite Horizon Pump IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Vista Pump IV Sets, Ultrasite Vista Pump IV Sets, Ultrasite IV Sets, Clave IV Sets, and Clave Primary ADDitIV IV Sets. Common Name: Intravascular Administration Set. 

CODES a) Catalog numbers CC1270, CC1271, CC1290, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D,

NF3160, NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24,  V1445-30, V1445-44, V1446, V1447, V1449-12,

V1452, V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, and V7410-10.

The following Lot numbers are involved in the recall: 60053136, 60060573, 60060596, 60060607, 60060614, 60060630, 60060632, 60063756, 60063769, 60064892, 60067686, 60068313, 60070114, 60070183, 60070503, 60070903, 60070921, 60071429, 60071430, 60072370, 60073185,

60074375, 60074376, 60075886, 60075964, 60075965, 60076494, 60076554, 60076560, 60076562, 60076652, 60076655, 60076659, 60076740, 60076746, 60076757, 60078427, 60078438, 60078439, 60078445, 60078452, 60078455, 60078853, 60078918, 60079388, 60081052, 60082545, 60082630, 60083490, 60083977, 60083979, 60083980, 60083981, 60083983, 60083984, 60084051, 60084058, 60084074, 60085504, 60088341, 60088485, 60088577, 60088695, 60088855, 60088858, 60088866, 60088867, 60088868, 60088872, 60088873, 60088876, 60088928, 60089309, 60089313, 60089328, 60089432, 60090779, 60090783, 60090805, 60091132, 60091137, 60091140, 60091148, 60091149, 60091150, 60091162, 60091458, 60091459, 60091460, 60091463, 60091467, 60091470, 60091474, 60092542, 60092686, 60092733, 60093306, 60093307, 60093309, 60093313, 60093314, 60093573, 60093600, 60093605, 60093609, 60093619, 60093881, 60094452, 60095083, 60095252, 60095789, 60095792,

60095813, 60095830, 60095835, 60095843, 60095845, 60095846, 60095847, 60095848, 60095850, 60095851, 60096116, 60096176, 60096199, 60096206, 60096218, 60096231, 60096485, 60097397, 60097407, 60097416, 60097686, 60097687, 60097688, 60097691, 60097695, 60097697, 60097699, 60097703, 60097711, 60097723, 60097725, 60097727, 60098003, 60098007, 60098066, 60098085, 60098092, 60098098, 60098141, 60098218, 60099589, 60099692, 60099903, 60100061, 60100320, 60100321, 60100327, 60100328, 60100332, 60100610, 60100615, 60100624, 60100627, 60100639, 60101312, 60101701, 60101702, 60101703, 60101728, 60101733, 60101932, 60102181, 60102300, 60102320, 60102330, 60102560, 60102647, 60102652, 60102654, 60102656, 60102657, 60102720, 60102722, 60102744, 60103171, 60103174, 60103910, 60104238, 60104240, 60104246, 60104249, 60104250, 60104261, 60104267, 60104269, 60104272, 60104883, 60104929, 60105356, 60105370, 60105372,

60105816, 60106045, 60106053, 60106064, 60106066, 60106289, 60106310, 60106314, 60106412, 60106772, 60107539, 60107540, 60107573, 60107610, 60107690, 60107937, 60107938, 60109024, 60109986, 60111419, 60111420, 60111422, 60111430, 60111434, 60111436, 60111464, 60111466, 60111467, 60111468, 60111472, 60112240, 60112241, 60113258, 60113263, 60113266, 60113268, 60113272, 60113281, 60113285, 60113371, 60113389, 60113391, 60113394, 60113396, 60113397, 60113478, 60113512, 60113514, 60113517, 60113764, 60114081, 60115239, 60115378, 60115379, 60115465, 60115493, 60115657, 60116531, 60116541, 60116542, 60116563, 60116599, 60116601, 60116658, 60116897, and 60118838.

b) Catalog numbers CC1270, CC1271, CC1290, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D, NF3160,

NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24, V1445-30, V1445-44, V1446, V1447, V1449-12, V1452,

V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, and V7410-10.

The following Lot numbers are involved in this recall: 60202057, 60202059, 60204396, 60204399, 60204563, 60206655, 60206671, 60211413, 60211414, 60213590, 60213594, 60215815, 60218346, 60218349, 60218373, 60218607, 60219461, 60219481, 60221910, 60223949, 60223965, 60223973, 60223976, 60224952, 60225296, 60228002, 60229236, 60230334, 60230342, 60234884, 60234884, 60235982, 60236759, 60236775, 60242007, 60242010, 60243129, 60243130, 60243132, 60243135, 60243136, 60243138, 60243583, 60243586, 60243588, 60243599, 60244153, 60244154, 60244155, 60244180, 60244209, 60244210, 60244211, 60244214, 60244217, 60244219, 60244370, 60245338, 60245340, 60245341,

60245342, 60245360, 60245362, 60245364, 60245369, 60246702, 60246971, 60246972, 60246973, 60246975, 60246976, 60246977, 60246978, 60246978, 60246979, 60246980, 60247404, 60247429, 60248250, 60248250, 60248313, 60248315, 60248318, 60248322, 60248329, 60249590, 60249732, 60250052, 60250053, 60250054, 60250055, 60250057, 60250065, 60250261, 60251486, 60251488, 60253762, 60253770, 60253776, 60254072, 60254073, 60254074, 60254075, 60254077, 60254078, 60254080, 60254081, 60254086, 60255310, 60255311, 60255312, 60255317, 60255318, 60255321, 60256117, 60256123, 60256147, 60256148, 60256157, 60256160, 60256162, 60257354, 60257373, 60258119, 60258158, 60258159, 60258161, 60258163, 60258167, 60258168, 60259837, 60259868, 60260586, 60260587, 60260592, 60260594, 60260607, 60261925,

60261937, 60261961, 60261976, 60261977, 60262821, 60262823, 60262839, 60262848, 60262849, 60263719, 60263724, 60263725, 60263752, 60263859, 60264549, 60264606, 60264609, 60264613, 60264614, 60264620, 60265844, and 60265845.

RECALLING FIRM/MANUFACTURER Braun Medical, Inc. Allentown, PA

REASON a) Inadequate bonding of tube to bottom cap of the drip chamber may cause leaking

b) tubing may disconnect from Universal Drip Chamber

VOLUME OF PRODUCT IN COMMERCE a) 53,864 cases; b) 44521 cases

DISTRIBUTION Nationwide and Canada

 

PRODUCT SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter

CODE Catalog number H74908251041: 4174749, 4181061, 4190629, 4200473, 4200474, 4200475 and4282946;

Catalog number H74908251081: 4181059, 4184618, 4187511 and 4203048

RECALLING FIRM/MANUFACTURER Boston Scientific Scimed Maple Grove, MN

REASON Some of the recalled Coronary Infusion Catheters have side holes which are partially or completely blocked.

VOLUME OF PRODUCT IN COMMERCE 55 catheters.

DISTRIBUTION Nationwide and Japan.

 

PRODUCT Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL or Baxter Healthcare Corporation, McGaw Park, IL

CODE All System 1000 instruments are affected, and include the following serial number ranges, 1001S to 1142S, 50001 to 52109, and 01001 to 19250.

RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp. Round Lake, IL

Manufacturer: Baxter/Althin Medical, Inc. Miami Lakes, FL.

REASON Spontaneous Dialysate Proportioning Ratio change.

VOLUME OF PRODUCT IN COMMERCE  Approximately 20,500 units.

DISTRIBUTION Nationwide and International.