JANUARY 2002

WEEK ENDING JANUARY 12

 

PRODUCT a) BD Angiocath Autoguard, REF 381707, 16 GA 1.16 IN., Cat. 381707;

b) BD Insyte Autoguard, REF 381434, 20 GA 1.16 IN., Cat. 381434.

CODE

a) BD Angiocath Autoguard Catheter, , Lot No. 106170; b) BD Insyte Autoguard Catheter, Lot No. 108010.

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

REASON Unit packages have microscopic perforations.

VOLUME OF PRODUCT IN COMMERECE 32,400 units.

DISTRIBUTION Nationwide.

 

PRODUCT Baxter Spinal Anesthesia Trays, a sterile, single use only, anesthesia conduction kit labeled as "Non-Latex Components,

a) Baxter Spinal Anesthesia Tray: Sprotte Spinal Needle with Stylet, 24 Ga x 8.9 cm (3-1/2"), 5% Lidocaine Hydrochloride and 7.5% Dextrose

Injection, USP, 2 mL.  ;

b) Baxter Spinal Anesthesia Tray: Whitacre Spinal Needle with Stylet, 25 Ga x 8.9 cm (3-1/2") TW High Flow, 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2 mL,.

CODE a) Product code 1T2348, lots GD738922, GD739813, GD741694; b) Product code 1T2356, lots GD738930, GD739821, GD742882.

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

Manufacturer: Baxter Healthcare Corp., Cleveland, MS. 

REASON Trays labeled as Non-Latex Components contain syringes with a latex stopper.

VOLUME OF PRODUCT IN COMMERECE Nationwide.

DISTRIBUTION 6,907 trays.

 

PRODUCT Quickie brand P-222, Powered Wheelchair.

CODE The part number involved is for a PG10 Pilot + 65 amp controller, part number 910115, Model #:  P-222, Serial # Range: P22-8516 to P22-9181

RECALLING FIRM/MANUFACTURER Sunrise Medical, Fresno, CA

REASON While in operating mode, an unanticipated stop can occur.

VOLUME OF PRODUCT IN COMMERECE 652 units.

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT Quickie brand G-424, S-525, S-626, V-521, Powered Wheelchair,

CODE

Model #     Serial Number Range:

G-424       G42-6010 to G42-12531

S-525       S52-10060 to S52-17155

S-626       S62-5801 to S62-11281

V-521       V52-10786 to V52-12221

RECALLING FIRM/MANUFACTURER Sunrise Medical Quickie Designs, Inc., Fresno, CA

REASON The dual-post clamping armrest receiver can collapse from the wheelchair.

VOLUME OF PRODUCT IN COMMERECE 12,322 units.

DISTRIBUTION Worldwide and nationwide.

 

PRODUCT LCV+, LCA, LCA+, LC+, LCN+, LCLP+ Angiographic X-ray Systems, Model Numbers 2120351, 2120351-2, 2219157, 2219157-2, 2251041, 2154096, 2219156, and 2251039

CODE All serial numbers are affected.

RECALLING FIRM/MANUFACTURER Recalling Firm: General Electric Medical Systems, Waukesha, WI

Manufacturer: GE Medical Systems Europe Buc Cedex, France. 

REASON The C-arm can move at a high rate of speed forcing the collimator into the bottom of the tabletop. 

VOLUME OF PRODUCT IN COMMERECE Nationwide and worldwide.

DISTRIBUTION 1263 units.

 

PRODUCT a) ACS Polyethylene Insert, 20 degree, 26 mm.  Product code 1115-42-025; 

b) Global Shoulder Enduron Glenoids.  Product codes 1137-85-025, 1137-86-025, 1137-87-025, 1137-93-025, 1137-94-025, 1137-95-025, 1137-96-025, 1137-97-025 and 1137-98-025;

c) Global Shoulder Enduron +3 Glenoids.  Product codes 1137-84-030, 1137-85-030, 1137-86-030, 1137-87-030, 1137-89-030, 1137-93-030, 1137-94-030, 1137-95-030, 1137-96-030, 1137-97-030, 1137-98-030 and 1137-99-030;

d) LCS Mensical Bearings.  Product codes 1178-20-025, 1178-21-025, 1178-22-025, 1178-23-025, 1178-24-025, 1178-25-025, 1178-26-025, 1178-27-025, 1178-28-025, 1178-29-025, 1178-46-025, 1178-47-025, 1178-48-025, 1178-51-025, 1178-52-025, 1178-53-025, 1178-54-025, 1178-55-025, 1178-56-025, 1178-57-025, 1178-58-025, 1178-59-025, 1178-61-025, 1178-62-025, 1178-63-025 and 1178-64-025;

e) LCS Textured Patella.  Product code 1180-14-025;

f) Pinnacle Marathon Acetabular Liners, 28 mm.  Product codes 1219-28- 054, through 1219-28-062 and 1219-28-148 through 1219-28-162;

g) Pinnacle Marathon Acetabular Liners, 36 mm.  Product code 1219-36- 466;

h) Duraloc Marathon Acetabular Liners, 28 mm.  Product codes 1220-28-048 through 1220-28-064, 1220-28-148 through 1220-28-166, 1220-28-248 through 262 and 1220-28-452 through 1220-28-462;

i) Duraloc Marathon Acetabular Liners, 32 mm.  Product codes 1220-32-052 through 1220-32-066, 1220-32-152 through 1220-32-164 and 1220-32-456 through 1220-32-466;

j) S-ROM Marathon Liner M, 28 mm.  Product codes 1220-70-028, 1220-70-128 and 1220-70-328;

k) S-ROM Marathon Liner L, 28 mm.  1220-71-028 and 1220-71-328;

l) S-ROM Marathon Liner L, 32 mm.  Product codes 1220-72-032, 1220-72-132 and 1220-72-332;

m) NeuFlex Finger.  Product codes 1234-00-000, 1234-10-000, 1234-40-000 and 1234-60-000;

n) Duraloc Enduron Liners.  Product codes 1239-50-025 through 1239-66-025;

o) Duraloc Enduron Liners.  Product codes 1240-10-025 through 1240-18-025 and 1240-48-025 through 1240-58-025;

p) Duraloc Enduron Liners.  Product codes 1241-08-025 through 1239-26-025 and 1241-48-025 through 1241-64-025;

q) Duraloc Enduron Liners.  Product codes 1241-08-526 through 1241-16-526, 1241-24-526 and 1241-40-526 through 1241-60-526;

r) Duraloc Constrained Liners, 28 mm.  Product codes 1241-08-527 through 1241-22-527;

s) Duraloc Bantam Liners.  Product codes 1241-44-527 through 1241-46-527;

t) Duraloc Enduron Liners. Product codes 1242-12-025 and 1242-54-025 through 1242-62-025;

u) Duraloc Enduron Liners.  Product codes 1242-12-526 through 1242-16-526;

v) Duraloc Constrained Liners, 32 mm.  Product codes 1242-12-527 through 1242-22-527;

w) Duraloc Enduron Liners.  Product codes 1261-48-526 through 1261-56-526;

x) LCS Rotating Bridging Bearings.  Product codes 1278-14-025 through 1278-16-025 and 1278-47-025 through 1278-55-025;

y) LCS Meniscal Bridging Bearings.  Product codes 1278-24-025 through 1278-26-025;

z) LCS Deep Dish Rotating Bearings.  Product codes 1278-56-025 through 1278-87-025;

AA) LCS Rotating Platform Bearings.  Product codes 1290-14-025 and 1290-16-025;

BB) AMK 3 Peg Patella.  Product code 1484-92-025;

CC) AMK Tibial Inserts.  Product codes 1488-19-025, 1488-41-025 through 1488-45-025, 1488-51-025 through 1488-55-025, 1488-61-025 through 1488-63-025 and 1488-81-025 through 1488-83-025;

DD) Coordinate Tibial Inserts.  Product codes 1492-42-025 through 1492-65-025;

EE) LCS 3 Pegged Patella.  Product codes 1497-73-025 through 1497-76-025;

FF) Agility Ankle Tibial Inserts.  Product codes 1555-31-0000 through 1555-36-000;

GG) AMK Constrained Tibial Inserts.  Product codes 1688-41-025 through 1688-43-025, 1688-51-025 through 1688-52-025 and 1688-61-025 through 1688-62-025;

HH) Acclaim Elbow Pin Assembly.  Product code 1722-80-000;

II) LCS 3 Pegged Rotating Patella.  Product codes 1779-82-025 through 1779-86-025;

JJ) AMK Congrucency PS Tibial Inserts.  Product codes 1956-41-025, 1956-42-025, 1956-51-025, 1956-53-025 and 1956-62-025.  

CODE

Product 111542025:  Lots SC8NXA001, TW3AAA001;

Product 113644998:  Lot V2YE21001;

Product 113784025:  Lots V2YAB1007, V2PBS1006, V2YAB1024, V2PBS1005, V2YAB1005, V2YAB1002;

Product 113784030:  Lots V2GBF1006, V2GBF1007, V2GBF1011;

Product 113785025:  Lots V1WEP1003, V1WEP1004, V1WEP1007, V2PBW1015, V24A91013, V16C11001, V16C11010, V2YAC1014, V1WEP1002, V16C11007, V1WEP1005, V2YAC1020, V24A91008, V1WEP1006, V2YAC1019, V16C11004, V16C11003, V2YAC1003, V2YAC1009, V16C11002, V2YAC1012, V24A91004, V16C11008, V16C11005, V1WEP1011, V1WEP1012;

Product 113785030:  Lots V2GBG1007, V2GBG1008, V2GBG1009;

Product 113786025:  Lots V24BA1009, V21B61013, V2ED81007, V2ED81004, V2ED81005, V24BA1002, V24BA1004, V24BA1014, V21B61010, V24BA1018, V21B61009, V2ED81006, V2ED81008, V2ED81001, V24BA1021, V21B61004, V24BA1010, V21B61003, V21B61015;

Product 113786030:  Lots V2GBH1014, V2GBH1006, V2GBH1016;

Product 113787025:  Lots V24BB1008, V24BB1001, V24BB1013, V16C21005, V16C21009, V16C21008, V21B81003, V21B81008, V24BB1009, V24BB1002;

Product 113787030:  Lots V2GBJ1014, V2GBJ1011, V2GBJ1017;

Product 113788030:  Lots V2GBK1006, V2GBK1003, V2GBK1011;

Product 113789030:  Lots V2GBL1007, V2GBL1008, V2GBL1010;

Product 113793025:  Lots V2RF61006, V2RF61010;

Product 113798025:  Lots V2RGA1003, V2RGA1007;

Product 113793030:  Lots V2VC91011, V2VC91004, V2VC91017;

Product 113794030:  Lots V2VDA1001, V2VDA1009, V2VDA1017;

Product 113795030:  Lots V2VDB1016, V2VDB1006, V2VDB1007;

Product 113796030:  Lots V2VDC1006, V2VDC1010, V2VDC1011;

Product 113797030:  Lots V2WAW1012, V2WAW1013, V2WAW1016;

Product 113798025:  Lots V2RGA1003, V2RGA1007;

Product 113798030:  Lots V2WAX1003, V2WAX1012, V2WAX1013;

Product 113799030:  Lots V2WAY1008, V2WAY1006, V2WAY1007;

Product 113794025:  Lots V21CB1013, V21CB1008, V2PBY1011, V2ED91009, V2PBY1016, V21CB1010, V2ED91007, V2PBY1004, V21CB1005, V21CB1003, V2ED91005, V2ED91008;

Product 113795025:  Lots V2RF71016, V2RF71024, V2RF71008, V2RF71017, V2RF71020, V16C31008, V2RF71018, V2RF71019, V2RF71027, V2RF71025, V2RF71022, V2RF71006, V24BC1007, V24BC1002, V24BC1008, V2RF71010, V2RF71005, V16C31006, V2RF71014;

Product 113796025:  Lots V2RF81005, V2RF81004, V24BD1002, V24BD1006, V16C41004, V2RF81007, V24BD1005, V16C41006, V24BD1007, V24BD1008, V24BD1001, V16C41002;

Product 113797025:  Lots V2EEA1009, V2EEA1002, V2EEA1003, V2RF91007, V2RF91009, V2RF91001, V2RF91010, V2RF91005, V2EEA1007, V2EEA1008, V2EEA1010;

Product 117820025:  Lots V15JN1012, V15JN1004, V15JN1010, V15JN1005, V3TA81009, V15JN1001, V15JN1007, V15JN1006, V15JN1011;

Product 117824025:  Lots V15JP1010, V15JP1002, V15JP1007, V15JP1003;

Product 117825025:  Lot V24GV1013;

Product 117829025:  Lot V2WE51004;

Product 117846025:  Lots V25CW1013, V33MD1003, V3TJD1016, V3TJD1017, V3TJD1014, V33MD1001, V3TJD1008, V3DCR1008, V25CW1003, V25CW1003, V33MD1025, V33MD1002, V3DCR1002, V33MD1010, V33MD1019, V33MD1035, V3DCR1003, V3TJD1019, V25CW1018, V25CW1018, V3TJD1018, V33MD1021, V3TJD1020, V33MD1017, V33MD1024, V33MD1007, V3TJD1006, V3DCR1004, V3DCR1012, V33MD1030, V33MD1032, V33MD1023, V33MD1016, V3DCR1014, V2LB61006, V33MD1018, V33MD1029, V3DCR1009, V25CW1012, V25CW1012, V3DCR1005, V3DCR1011, V25CW1009, V33MD1027, V3TJD1013, V2LB61007, V3TJD1015, V33MD1031, V3DCR1007, V3TJD1010, V3TJD1011;

Product 117847025:  Lots V3FFM1001, V3FFM1008, V2CBH1005, V3BCD1006, V25CX1007, V3FFM1006, V3FFM1011, V25CX1004, V2CBH1006, V3BCD1008, V3BCD1001, V25CX1008, V25CX1005, V3FFM1010, V3FFM1017, V3FFM1013, V3FFM1003, V25CX1010, V3FFM1019, V3FFM1016, V25CX1006, V3BCD1005, V2CBH1002, V3BCD1010, V2CBH1009, V3FFM1012;

Product 117848025:  Lots V2CBK1007, V2CBK1002, V2CBK1006, V2CBK1005, V3LB11006, V2CBK1008;

Product 117851025:  Lots V2VB41013, V27AS1003, V2VB51011, V3LB21001, V2VB51014, V3DCS1013, V27AS1024, V24AT1013, V3DCS1003, V24AT1019, V3LB21015, V3DCS1001, V24AT1018, V3DCS1008, V27AS1006, V3LB21007, V24AT1011, V3DCS1012, V24AT1001, V3DCS1004, V27AS1005, V3LB21016, V2VB41014, V24AT1012, V27AS1020, V24AT1003, V2VB51003, V2VB51006, V3DCS1019, V3DCS1017, V3DCS1014, V27AS1014, V3DCS1006, V24AT1007, V24AT1008, V3DCS1020, V2VB51005, V3LB21011, V24AT1004, V27AS1002, V24AT1002, V27AS1025, V3LB21010, V3DCS1016, V3DCS1002, V2VB41023, V27AS1004, V27AS1010, V27AS1011, V27AS1008, V3DCS1009, V24AT1014;

Product 117852025:  Lots V3EA31013, V27AV1003, V27AV1006, V24AV1006, V24AV1008, V3EA31001, V2VB61001, V2VB61008, V3EA31009, V3EA31008, V3EA31012, V27AV1010, V2VB61007, V3EA31005, V24AV1004, V24AV1007, V3EA31006, V24AV1005, V3EA31011, V2VB61002, V2VB61009, V3EA31003, V3EA31007, V24AV1002, V27AV1004, V3EA31002;

Product 117853025:  Lots V16HL1006, V16HL1004, V16HL1005, V2VB81003, V2VB81001, V16HL1003, V16HL1003, V16HL1009, V3VEB1018, V2VB81002, V16HL1001, V16HL1010;

Product 117856025:  Lots V26CR1011, V2YBD1022, V3KG61020, V3WE51001, V3BAB1012, V3BAB1002, V3BAB1008, V3DCT1003, V2YBD1011, V3DCT1021, V2YBF1009, V2YBD1017, V2YBF1009, V2YBF1001, V2YBF1006, V3BAB1006, V2YBD1005, V2YBF1005, V3BAB1016, V3WE61011, V3KG61002, V3KG61015, V2YBD1023, V3BAB1017, V3KG61008, V3WE61008, V3KG51015, V3WE51016, V3WE61012, V3BAB1011, V3KG61001, V2YBD1020, V3KG61005, V3WE61013, V2YBF1015, V3WE51029, V3KG61013, V3KG61016, V3WE51023, V26CR1008,

V3WE51025, V3WE51017, V3KG61004, V3WE61010, V26CR1017, V3WE51034, V3WE51008, V2YBD1012, V3WE61009, V2YBD1003, V3KG61017, V3WE51031, V3KG61019, V3WE51019, V3WE61005, V3KG61006, V3WE51030, V2YBD1009, V2YBD1016, V3BAB1014, V3WE51004, V3DCT1001, V3DCT1016, V2YBD1002, V3KG61007, V3KG61009, V3BAB1007, V3WE61014;

Product 117857025:  Lots V3FFN1007, V3BAA1021, VBAA1002, V3BAA1013, V3BAA1019, V3BAB1019, V3BAA1024, V3FFN1013, V3BAA1014, V3BAA1026, V3BAA1015, V3FFN1004, V3BAA1027, V3FFN1003, V3FFN1005, V3FFN1008, V3BAA1008, V3BAA1022, V3BAA1030, V3FFN1014, V3BAA1001, V3FFN1020, V3BAA1023, V3FFN1006, V3FFN1019, V3BAA1006;

Product 117858025:  Lots V2EBE1010, V2KHB1002, V2KHB1007, V2KHB1005, V2KHB1010, V2KHB1003, V2EBE1004, V2EBE1001, V2KHB1006, V2KHB1001, V2EBE1006;

Product 117859025:  Lot V26CT1004 ;

Product 117861025:  Lots V26CV1001, V2LER1007, V2YA91006, V26CV1002, V2LER1004, V2LER1023, V2LER1003, V2LER1002, V2YA91010, V26CV1006, V2YA91004, V26CV1012, V26CV1015, V2LER1017, V2LER1021, V26CV1010, V26CV1013, V26CV1004;

Product 117862025:  Lot V2EDR1005;

Product 117864025:  Lots V2LES1006, V2LES1010;

Product 121928054:  Lot US3DMA001;

Product 121928056:  Lots U12AXA001, U2ACGA001;

Product 121928062:  Lot U2FC2B001;

Product 121928150:  Lot U69HYA001;

Product 121928160:  Lot U69H2B001;

Product 121936466:  Lot V3YEC1042, V3YEC1004, V3YEC1029;

Product 122028050:  Lot UH4KHB001;

Product 122028152:  Lots VC5AXB001, UL8FSB001, UJ9FJA001;

Product 122028154:  Lots VB1BRC002, VJ7FRA001;

Product 118014025:  Lots V15JC1009, V15JC1004, VX8BB1006, V15JC1012, V15JC1002, V15JC1003, VX8BB1008, V15JC1006, V15JC1005, V15JC1008;

Product 121928148:  Lot U56A7A001;

Product 121928162:  Lots V16J81058, V16J81039, V16J81005, V16J81025, V16J81049, V16J81026, V16J81027, V16J81029, V16J81031, V16J81030,

V16J81050, V16J81059, V16J81038, V16J81041, V16J81002, V16J81053, V16J81028, V16J81008, V16J81032, V16J81037, V16J81042, V16J81054,

V16J81056, V16J81033, V16J81034, V16J81035, V16J81036, V16J81055;

Product 122028054:  Lot U53BXB001;

Product 122028148:  Lots VF1C8A001, UH5J2B001;

Product 122028158:  Lots U2YBMB001, U34FBB001, VK8DAA001, U74CCA001;

Product 122028262:  Lot U78F8B001;

Product 122028048:  Lots U4FCEA001, VR7FEA001;

Product 122028248:  Lot U78F1A001;

Product 122028460:  Lot U5DEFB001;

Product 122028452:  Lot VG3KVA001;

Product 122028462:  Lot VG3KPA001;

Product 122032054:  Lot VB2CJA001;

Product 122032456:  Lots V3KA21013, V3KA21001;

Product 122060998:  Lot V3BAE1001;

Product 122028056:  Lots VB6C2A003, VB6C2A002, VF1DAA001;

Product 122028060:  Lot VD2FDB001, VB6LFA001, U3NECB001, U29CXB001;

Product 122028150:  Lots U66C6C001, VD2L1C002, U88EGD001, U88EGD002, UD1B4B001;

Product 122028160:  Lots U5DAPB001, UR1FAB001, U3NNGA001, VC4GJB001;

Product 122028258:  Lots VE2A5A001, VD5A5A001;

Product 122028458:  Lots VB2CFA001;

Product 122032056:  Lots V3TFH1015, U4DA8A001, U54A7B001, VB2CKA001, V3TFH1002;

Product 122032058:  Lots VD4EWB001, UD7J6A001, VB2FWC002, VD4EWA001, VB2FWC001;

Product 122032066:  Lot U3DGKA001;

Product 122032160:  Lots U88BEB002;

Product 122032462:  Lots V2VCC1004, V2VCC1011, V2VCC1006, V2VCC1010, V2VCC1002, V2VCC1008, V2VCC1014, V2VCC1005, V2VCC1012, V2VCC1019, V2VCC1017, V2VCC1003, V2VCC1009;

Product 122032466:  Lots V33EG1002, V33EG1011;

Product 123960025:  Lots 519876001, 601756001;

Product 123966025:  Lots 602996001, R58HJA001;

Product 124222527:  Lots V2VCB1015, V2VCB1007;

Product 127853025:  Lots V3CB11001, V3CB11002, V3NH41001, V3NH41005, V3NH41002, V3NH41004, V3NH41007, V3CB11010, V3CB11009, V3BCF1009, V3NH41006, V3VEC1004, V3CB11006;

Product 127885025:  Lots V3BEE1001, V3BEE1005, V3BEE1013, V3BEE1006, V3BEE1010, V3BEE1012, V3BEE1014, V3BEE1015;

Product 122028052:  Lots U27GLA001, U5SRTB001, U87ATA001;

Product 122028058:  Lots U66DFB002, U66DFB001;

Product 122028254:  Lots V2VDH1022, V2VDH1004, V2VDH1010, VA2LGB001, V2VDH1012, V2VDH1001, V2VDH1008, V2VDH1019, V2VDH1028, V2VDH1030, V2VDH1011, U2AC5A001, V2VDH1009, V2VDH1016, V2VDH1017, V2VDH1013, V2VDH1014, V2VDH1025, V2VDH1029, V2VDH1024, V2VDH1015, V2VDH1005, V2VDH1020;

Product 122028256:  Lots V2VDJ1015, V2VDJ1012, V2VDJ1025, V2VDJ1001, V2VDJ1021, V2VDJ1010, V2VDJ1013;

Product; 122028062:  Lots VB6LJA001, T81BMB001, U4FCHC001;

Product 122028064:  Lots VD2FHA001, UA3F1B001, U3LFWB001;

Product 122028156:  Lots VJ2BLA001, VC4GMB001, VC4GMC001;

Product 122028162:  Lots U66DAC001, VE8AMA002, UH6B1B001, U66DAD001;

Product 122028164:  Lots UL8F7A001, U96BHA004, UH7B1A001, U96BHA003, UE9FAA001;

Product 122028260:  Lots V28BS1002, V28BS1025, V28BS1019, V28BS1006, V28BS1024, V28BS1028, V28BS1007, VG7E1A001, V28BS1008, V28BS1010;

Product 122032152:  Lots V2VCD1018, V2VCD1030, V3KARA005, V2VCD1008, V2VCD1021, V3KAR1030, V2VCD1027, V2VCD1020, V2VCD1014, V2VCD1024, V2VCD1006, V2VCD1015, V2VCD1017, V3KARA001, V2VCD1011, V2VCD1022, V3KARA002, V2VCD1004, V3KARA003, V3KARA004, V2VCD1013, V2VCD1001, V2VCD1016, V2VCD1023, V2VCD1010, V2VCD1019, V2VCD1025;

Product 122070028:  Lots, V3DB51004, V3DB51016, V3DB51013, V3DB51007, V3DB51001, V3DB51015, V3DB51002, V3DB51009, V3DB51005,

V3DB51006, V3DB51019, V3DB51014, V3DB51003, V3DB51011, V3DB51018, V3DB51008;

Product 122070328:  Lots V3DB71014, V3DB71022, V3DB71028, V3DB71032, V3DB71020, V3DB71030, V3DB71012, V3DB71021, V3DB71029, V3DB71031, V3DB71026, V3DB71025, V3DB71004, V3DB71005, V3DB71013, V3DB71017, V3DB71027, V3DB71023, V3DB71009, V3DB71019, V3DB71010, V3DB71011, V3DB71008, V3DB71016, V3DB71003, V3DB71001, V3DB71015;

Product 122071028:  Lots V3DB81004, V3DB81001, V3DB81008, V3DB81010, V3DB81006, V3DB81009;

Product 122072032:  Lots V2XFJ1001, V2XFJ1002, V2XFJ1012, V2XFJ1013, V2XFJ1017, V2XFJ1007, V2XFJ1009, V2XFJ1015, V2XFJ1003, V2XFJ1005;

Product 122072132:  Lots V3DCA1003, V3DCA1001, V3DCA1016, V3DCA1022, V3DCA1007, V3DCA1017, V3DCA1018, V3DCA1005, V3DCA1008, V3DCA1009, V3DCA1010, V3DCA1023;

Product 122072332:  Lots V3DCB1025, V3DCB1004, V3DCB1005, V3DCB1017, V3DCB1019, V3DCB1028, V3DCB1031, V3DCB1015, V3DCB1022, V3DCB1007, V3DCB1008, V3DCB1018, V3DCB1026, V3DCB1003, V3DCB1009, V3DCB1014, V3DCB1021, V3DCB1006, V3DCB1016, V3DCB1027, V3DCB1013, V3DCB1023;

Product 122032158:  Lots V33EF1015, V33EF1006, V33EF1016, V33EF1008, V33EF1012;

Product 122032052:  Lots V3BDB1010, V3BDB1003, V3BDB1002, V3BDB1013, V3BDB1004, V3BDB1016, V3BDB1001, V3BDB1012;

Product 122032062:  Lots U2DN4B001, U88A8B001;

Product 122032154:  Lots V3KAV1010, V3KAV1001, V3KAV1017, V3KAV1020, V3KAV1028, V3KAV1006, V3KAV1021, V3KAV1024, V3KAV1005, V3KAV1012, V3KAV1018;

Product 122032164:  Lots V28D91023, V28D91002, V28D91010, V28D91006, V28D91030, V28D91011, V28D91009;

Product 122070128:  Lots V3DB61018, V3DB61002, V3DB61001, V3DB61003, V3DB61005, V3DB61008, V3DB61006, V3DB61013, V3DB61009, V3DB61010, V3DB61012, V3DB61017, V3DB61015, V3DB61016, V3DB61011, V3DB61007, V3DB61004;

Product 122071328:  Lots V3DB91007, V3DB91001, V3DB91010, V3DB91009, V3DB91011, V3DB91014, V3DB91012, V3DB91008;

Product 123400000:  Lots V3KFC1001, V3KFC1008, V3KFC1015, V3KFC1018, V3KFC1019, V3KFC1020, V3KFC1021, V3KFC1025, V3KFC1030, V3KFC1031, V3KFC1037, V3KFC1050, V3KFC1055, V3KFC1056, V3KFD1007, V3KFD1012, V3KFD1013, V3KFD1014, V3KFD1017, V3KFD1045, V3KFD1048, V3KFC1029, V3KFC1034, V3KFC1004, V3KFC1026, V3KFC1035, V3KFC1014, V3KFC1017, V3KFC1024, V3KFC1028, V3KFC1038, V3KFC1040;

Product 123440000:  Lots V3KFE1004, V3KFE1007, V3KFE1008, V3KFE1011, V3KFE1019, V3KFE1039, V3KFE1044, V3KFE1053, V3KFE1055, V3KFE1058, V3KFE1061, V3KFE1023, V3KFE1057, V3KFE1020, V3KFE1033, V3KFE1001, V3KFE1012, V3KFE1018, V3KFE1025, V3KFE1056, V3KFE1060, V3KFE1032, V3KFE1036, V3KFE1015, V3KFE1050;

Product 123410000:  Lots V3KFD1019, V3KFD1026, V3KFD1028, V3KFD1027, V3KFD1052, V3KFD1006, V3KFD1030, V3KFD1032, V3KFD1003, V3KFD1005, V3KFD1061, V3KFD1063, V3KFD1020, V3KFD1025, V3KFD1033, V3KFD1035, V3KFD1037;

Product 123460000:  Lots VJ7JGA001, VJ7JGA002, VJ7JGA008, VJ7JGA009;

Product 123950025:  Lot SL7LKA001;

Product 123952025:  Lot TE6DHA001;

Product 123954025:  Lot U12AKA001;

Product 123956025:  Lot T66B4B001;

Product 123958025:  Lot R77A6A001;

Product 124010025:  Lots VX8ET1007, VX8ET1001;

Product 124018025:  Lot TF1C4A001;

Product 124054025:  Lots UX2H8B001, 555376001;

Product 124048025:  Lot T3XDLA001;

Product 124050025:  Lots V2LAH1003, V2LAH1004, V2LAH1001, V2LAH1019, V2LAH1002, V2LAH1014, V2LAH1016, V2LAH1017, V2LAH1020;

Product 124058025:  Lot R74BHA001;

Product 124108025:  Lot 835606001;

Product 124114025:  Lots UA6AHA001, G9B7B001, TL7A4A001, T1RFLA001, U2XGSA001, UL8E8A001;

Product 124116527:  Lots V3KDS1030, V3KDS1001, V3KDS1019;

Product 124118025:  Lots U89CPA001, U5EBFB001, T6BC2B001, TY3B9A001, UT2HRA001;

Product 124122527:  Lots V24CT1011, V24CT1019, V24CT1010, V24CT1002, V24CT1007, V24CT1008, V24CT1005, V24CT1030;

Product 124124025:  Lots R43AJA001, 984477002, R3SCKA001, 730706001;

Product 124124526:  Lot S32EAA001;

Product 124144527:  Lots UW4GDB001, TY9FSA002, V2PFR1001;

Product 124110923:  Lot V3DEK1001;

Product 124114527:  Lots V3KDR1025, V3KDR1027, V3KDR1028, V3KDR1026;

Product 124122025:  Lots 870706001, 983086001, R58HWB001, 567886001;

Product 124140526:  Lot V2PFN1008;

Product 124142526:  Lots V2PFP1019, V2PFP1013;

Product 124148526:  Lots VY8F61011, VY8F61006, VY8F61010, VY8F61005, VY8F61019;

Product 124158025:  Lots UA5AFB001, T36GAA001, UE9NKA001, RS1GCA001;

Product 124158526:  Lot TF9BBA001;

Product 124180995:  Lots V19GL1001, V19GL1002, V19GL1003, V19GL1004, V19GL1005, V19GL1006, V19GL1007, V19GL1008, V19GL1009, V19GL1010;

Product 124216891:  Lot V24J51001;

Product 124214527:  Lots V24CX1022, V24CX1004, V24CX1007, V24CX1023, V24CX1020, V24CX1026, V24CX1025, V24CX1019, V24CX1011, V24CX1016, V24CX1002, V24CX1003, V24CX1009, V24CX1024, V24CX1012, V24CX1001;

Product 124260025:  Lot S4GACA001;

Product 124280993:  Lots V19GS1001, V19GS1002, V19GS1003, V19GS1004, V19GS1005, V19GS1006, V19GS1007, V19GS1008, V19GS1009, V19GS1010;

Product 124154025:  Lots UK8BEA001, UK8BEA002, U2PFEA001, U4CGGA001, UR8FVB001, S82CMA001, U5EBJB001;

Product 124156526:  Lots T4GCXA001, U3YE6A001;

Product 124162025:  Lots 124162025, 516426001, 837616001;

Product 124212527:  Lots V24CV1006, V24CV1007, V24CV1022, V24CV1003, V24CV1028, V24CV1023, V24CV1029, V24CV1021, V24CV1017, V24CV1004, V24CV1026, V24CV1015, V24CV1009, V24CV1018, V24CV1030, V24CV1011;

Product 124218025:  Lots R48C1A001;

Product 124218527:  Lots V24C11020, V3KDV1015, V3KDV1019, V24C11003, V3KDV1011, V3KDV1020, V3KDV1021, V3KDV1008, V24C11026, V24C11019, V24C11024, V24C11022, V3KDV1001, V3KDV1023, V3KDV1030, V3KDV1009, V24C11018, V24C11007, V3KDV1013, V3KDV1010, V3KDV1028, V3KDV1029, V24C11021;

Product 124108526:  Lots V2XD61013, V2XD61019, V2XD61012, V2XD61017, V2XD61015, V2XD61009;

Product 124108527:  Lot V2KGW1018;

Product 124110527:  Lots V2KGX1025, V2KGX1028, V2KGX1001, V2KGX1026, V2KGX1013, V2KGX1024, V2KGX1021;

Product 124154526:  Lots UX3BKA001, VH6CHA001;

Product 124164025:  Lots 586356001, UH5ECB001;

Product 124212526:  Lot S66B3A001;

Product 124110025:  Lots UT9J4A001, V2VK31016, UT9J4A002, V2VK31027, T4PC1A001, V2VK31058, V2VK31028, V2VK31057, V2VK31041, V2VK31043, V2VK31056, V2VK31014, V2VK31029, V2VK31034, V2VK31049;

Product 124110526:  Lots V2XD71038, V2XD71005, V2XD71003, V2XD71039, V2XD71030, SD7EKA001, V2XD71031, S1TD5A001, V2XD71041, V2XD71027, V2XD71029, TG1AWA001, V2XD71037;

Product 124112025:  Lots SH6LSA001, V2VK41105, V2VK41102, V2VK41090, V2VK41116, S46BRA001, UD6A6B001, V2VK41080, V2VK41078, V2VK41077, V2VK41101, V2VK41083, V2VK41089, V2VK41088, V2VK41085, V2VK41086, V2VK41118, V2VK41094, V2VK41074, V2VK41079, V2VK41092, 2VK41113, U5SE5A001, V2VK41110, V2VK41111;

Product 124116025:  Lots TA6ARA001, S1BAAA001, UX6A3A001;

Product 124116526:  Lot S82CHA001;

Product 124120527:  Lots V24CS1024, V24CS1009, V24CS1018, V24CS1006, V24CS1001, V24CS1022, V24CS1011, V24CS1019, V24CS1003, V24CS1020;

Product 124120025:  Lots UT2HSA001, V2WBK1004, V2WBK1014, V2WBK1024, V2WBK1011, TR1AHA001, UT2HSA002;

Product 124160526:  Lot T79BYA001;

Product 124256025:  Lots R41BKB001, S2JAVA001, T73AWA001, T1CA5A001, T51C5B001;

Product 124258025:  Lots UG7H1A001, T5VFKB001;

Product 124144526:  Lots V2PFT1001, V2PFT1015, V2PFT1018, V2PFT1019, V2PFT1021, V2PFT1023, V2PFT1024, V2PFT1012, V2PFT1022;

Product 124148025:  Lots R66DYA001, UH4KDA001;

Product 124150025:  Lots V2WBL1054, V2WBL1008, V2WBL1112, V2WBL1033, V2WBL1041, V2WBL1081, V2XAD1049, V2WBL1043, V2WBL1080, V2WBL1116, V2WBL1017, V2WBL1088, V2WBL1005, V2WBL1048, 870886001, RH7ERA001, V2WBL1119, T4RA1B001, V2WBL1084, TN6EWA001, V2WBL1100, V2WBL1002, V2WBL1002, V2WBL1106, V2WBL1106, V2WBL1042, V2WBL1099;

Product 124152526:  Lots TF1C3A001, T5WANA001;

Product 124156025:  Lots V24CP1116, SW7DDA001, UY3FXC001, V24CP1047, V24CP1088, V24CP1114, V24CP1099, V24CP1082, V24CP1104, UC6JYB001, V24CP1117, V24CP1043, V24CP1060, V24CP1098, V24CP1045, V24CP1110, V24CP1085, V24CP1046, V24CP1051, V24CP1109, V24CP1064, V24CP1077, V24CP1097, V24CP1105, V24CP1113, V24CP1044, V24CP1065, V24CP1056, V24CP1119, V24CP1111, V24CP1120

Product 124160025:  Lots V2XAE1077, V2XAE1084, T5FCHA001, V2XAE1006, V2XAE1097, V2XAE1066, V2XAE1020, V2XAE1033, S4RBFA001, V2XAE1088, UW7AMB001, 978936001, V2XAE1031;

Product 124146527:  Lots V2PFS1007, V2PFS1009, V2PFS1006;

Product 124152025:  Lots V3LF61046, V3LF61083, V3LF61085, V3LF61095, V3LF61081, V3LF61078, V2XAD1100, V2XAD1079, V2XAD1101, V3LF61090, V3LF61100, V3LF61110, UD7FLA001, V24CP1055, V24CP1106, V3LF61045, V2XAD1009, V2XAD1088, V2XAD1075, V3LF61042, V3LF61043, V2XAD1055, UR8FPA001, V3LF61069, V3LF61093, V2XAD1052, V2XAD1104, V3LF61041, V2XAD1107, V3LF61114, V2XAD1083, V3LF61096, V3LF61076, V2XAD1061, V2XAD1057, V2XAD1027, V2XAD1054, V2XAD1080;

Product 124216526:  Lots V2XD81005, V2XD81022, V2XD81006, V2XD81012, V2XD81010;

Product 124216527:  LotS V3KDT1019, V3KDT1008, V3KDT1023, V3KDT1002, V3KDT1004, V3KDT1003, V3KDT1017, V3KDT1030;

Product 124220527:  Lot V3TAY1030;

Product 124614999:  Lot V3KGL1001;

Product 126150526:  Lots V24G91029, U2DHHA001, V24G91001, V24G91017, V24G91004, V24G91022, V24G91034;

Product 126154526:  Lots V2NCG1033, V2NCG1025, V2NCG1005, V2NCG1032, V2NCG1020, V2NCG1027, V2NCG1030;

Product 126156526:  Lots V24HA1012, S19JXA001, UJ3J3B001, V24HA1013, V24HA1025, V24HA1032, V24HA1011;

Product 126152526:  Lot V2NCB1011, V2NCB1035, V2NCB1009, V2NCB1020, V2NCB1018, V2NCB1032, 561216001, V2NCB1030;

Product 126148526:  Lots V2NCA1003, V2NCA1009, V2NCA1017;

Product 127825025:  Lots V3LFL1006, V2WE61001;

Product 127826025:  Lots V3LFL1003, V3LFL1006;

Product 127815025:  Lots V3LB31011, V2LB81003, V3LB31006, V3LB31009, V2LB81007, V2LB81001, V2LB81011;

Product 127847025:  Lots V21F81004, V21F81002, V21F81008, V21F81010;

Product 127851025:  Lots V16HP1010, V16HP1034, V16HP1001, V16HP1027, V3CBJ1032, V16HP1014, V16HP1016, V16HP1007, V16HP1036, V3NH31005, V3TJM1024, V21CN1005, V3EAY1003, V3NH31006, V3NH31013, V3NH31017, V16HP1031, V3NH31010, V16HP1005, V16HP1013, V16HP1009, V24AW1020, V3NH31018, V3TJM1009, V3EAY1016, V3CBY1011, V24AW1011, V24AW1002, V24AW1021, V3NH31020, V16HP1004, V3TJM1012, V3EAY1007, V24AW1001, V3TJM1010, V3TJM1020, V3NH31011, V34CY1030, V16HP1017, V3NH31008, V24AW1027, V3NH31009, V16HP1003, V3NH31004, V3NH31016, V3TJM1014, V3EAY1011, V3EAY1018, V24AW1023;

Product 127852025:  Lots V3EA11002, V21CP1009, V3EA11016, V21CP1012, V3EA11007, V3EA11018, V3BCF1005, V3BCE1002, V3EA11001, V21CP1014, V3EA11006, V21CP1016, V3EA11003, V21CP1020, V21CP1011, V21CP1018, V3VEA1001, V21CP1008, V21CP1019, V3EA11020;

Product 127854025:  Lots V3VEE1007, V3VEE1005;

Product 127856025:  Lots V3BD31021, V3BD31010, V3BD31012, V3BD41008, V3BD31011, V3BD31022, V3BD41011, V3BD41025, V3BD11008, V3BD21025, V3BD41010, V3BD41016, V3BD31003, V3BD11018, V3BD31023, V3BD41001, V3BD31017, V3BD41026, V3BD41018, V3BD31006, V3BD31015, V3BD41007, V3BD41014, V3BD41006, V3BD41017, V3BD41023, V3BD21005, V3BD11004, V3BD31009, V3BD31024;

Product 127857025:  Lots V24F51007, V24F41016, V24F41009, V24F41001, V24F41015, V24F51009, V24F41004, V24F41020, V24F51020, V24F51025, V24F51017, V24F51021, V24F51008, V24F51002, V24F51018, V24F51016, V24F41002, V24F41003, V24F41007, V24F61006, V24F41013, V24F61003;

Product 127858025:  Lots V2VFH1021, V2VFH1006, V2VFG1019, V2VFG1020, V2VFH1018, V2VFH1005, V2VFG1017, V2VFH1011, V2VFG1006, V2VFH1016, V2VFG1016, V2VFG1023, V2VFG1008, V2VFH1001, V2VFH1022, V2VFG1005, V2VFH1004, V2VFG1011, V2VFH1010, V2VFG1025, V2VFG1015, V2VFG1001, V2VFG1021, V2VFG1012, V2VFG1024, V2VFH1012, V2VFG1014, V2VFH1009, V2VFH1026, V2VFG1002, V2VFH1002, V2VFG1009;

Product 127859025:  Lots V2VFD1011, V2VFD1001, V2VFD1013, V2VFD1017, V2VFD1008, V2VFD1003;

Product 127814025:  Lots V2LB71010, V2LB71012, V2LB71002;

Product 127816025:  Lot V25CY1007;

Product 127864025:  Lots V2VFJ1001, V2VFJ1004, V2VFJ1014, V2VFJ1008, V2VFJ1016, V2VFJ1020;

Product 127886025:  Lots V3BEF1010, V3BEF1014, V3BEF1009, V3BEF1016, V3BEF1017, V3BEF1012, V3BEF1001;

Product 127861025:  Lots V2RCM1008, V3BD61024, V3KFS1021, V3KFS1025, V3KFS1003, V3KFS1020, V3KFS1024, V3KFS1009, V3TF21009, V3TF21011, V3BD61020, V2RCM1012, V3TF21002, V3KFS1019, V3BD61011, V3TF21001, V3TF21008, V3TF21010, V3BD61016, V3KFS1008, V3TF21005, V2RCM1009, V2RCM1009, V2RCM1011, V3KFS1011, V2RCM1013, V3KFS1018, V3KFS1004, V3KFS1022, V3KFS1023, V3KFS1005, V3KFS1012, V3KFS1007, V3BD61013, V3BD61014, V3TF21006;

Product 127862025:  Lots V3BD71005, V3BD71016, V3BD71015, V3BD71023, V3BD71007, V3BD71022, V3BD71001, V3BD71017;

Product 127866025:  Lots V3BD81001, V3BD91024, V3KFT1002, V3KFT1012, V3BD81025, V3BD81014, V3BD91015, V3BEA1009, V3BD91012, V3KFT1008, V3BD91020, V3BD91004, V3BD91006, V3BD81004, V3BEA1010, V3BD81015, V3BD81016, V3KFT1014, V3BD81017, V3BD91009, V3BEA1001, V3BD91021, V3BD91003, V3KFT1009, V3KFT1005, V3BD91011;

Product 127867025:  Lots V3BEB1007, V2VFK1001, V3TF51016, V3TF51015, V3TF51002, V3TF51024, V2VFK1003, V3BEB1012, V3BEB1016, V3TF51020, V3TF51007, V3TF51003, V3TF51022, V3TF51019, V2VFK1010, V3TF51010, V3BEB1013;

Product 127824025:  Lot V15JR1006;

Product 127871025:  Lot V2KC1A001;

Product 127883025:  Lots V3BEC1016, V3BEC1009, V3BEC1013, V3BEC1018, V3BEC1015, V3TF71020, V3TF71005, V3BEC1014, V3BEC1022, V3TF71001, V3TF71009, V3TF71012, V3TF71025, V3BEC1019, V3TF71006, V3BEC1001, V3BEC1002, V3BEC1025, V3BEC1024, V3TF71010, V3TF71024;

Product 127884025:  Lots V3BED1007, V3TGA1011, V3BED1004, V3TF91006, V3TF91013, V3TGA1003, V3BED1006, V3TGA1007, V3BED1010, V3BED1002, V3TF91022, V3TF91007, V3TF91011, V3TGA1006, V3TGA1004, V3TGA1010, V3BED1003, V3TF91017;

Product 129014025:  Lots V21GA1006, V21GA1004;

Product 129016025:  Lot V2LCE1003;

Product 148492025:  Lot V3BLJ1011;

Product 148819025:  Lots V2DBC1028, V18AK1001, V2DBC1032, V2DBC1036, V18AK1008, V18AK1016, V2DBC1005, V2DBC1006K, V2DBC1031, V2DBC1042, V2DBC1013, V2VBG1035, V2DBC1002, V2DBC1043, V18AK1023, V18AK1007, V2VBG1032, V2VBG1038, V2VBG1044, V2DBC1010, V2VBG1014, V1PGNA001, V2VBG1001, V18AK1017, V18AK1044, V2DBC1014, V18AK1025, V2DBC1020,

V2DBC1021, V2VBG1012, V2DBC1041, V2DBC1033, V2DBC1026, V2VBG1029, V2DBC1039, V2VBG1004, V2VBG1010, V2VBG1041, V18AK1012;

Product 148841025:  Lots V1WEW1006, V2VKG1007, V2KA11004, V2VKG1021, V3KHE1018, V1WEW1004, V3KHE1005, V3KHE1026, V3KHE1002, V3KHE1010, V1WEW1013, V1WEW1019, V3KHE1011, V3KHE1024, V3KHE1032, V2KA11011, V2KA11007, V2VKG1015, V2VKG1001, V2VKG1008, V3KHE1003, V1WEW1003, V1WEW1014, V3KHE1013, V2KA11003;

Product 148842025:  Lots V3CBH1002, V2KA21005, V2KA21032, V2KA21017, V1HD51005, V2KA21004, V3CBH1005, V3CBH1008, V2KA21033, V2KA21001, V1HD51001, V1HD51003, V2KA21036, V3CBH1009, V2KA21023;

Product 148843025:  Lots V15AK1001, V2KA31006, V2CBA1011, V2CBA1004, V24AL1003, V15AK1002, V2CBA1008, V3KHG1012, V2CBA1005;

Product 148845025:  Lot V2CBC1012;

Product 148851025:  Lots V3CBJ1010, V2ED21010, V2KA61001, V3CBJ1020, V3CBJ1017, V3CBJ1029, V3CBJ1006, V3CBJ1011, V3BB51007, V3KAY1026, V3CBJ1026, V3CBJ1004, V3CBJ1015;

Product 148852025:  Lots V2ED31004, V2VKK1008, V2VKK1002, V2VKK1001, V2VKK1010, V2PBM1011, V2VKK1005, V15B41009, V2ED31003, V15B41007, V2ED31011, V2PBM1006, V2VKK1012;

Product 148853025:  Lots V2PBN1002, V2PBN1012, V2PBN1003, V2PBN1001, V2PBN1004, V2PBN1006, V2PBN1011;

Product 148855025:  Lots V2ED41009, V2ED41001, V2ED41005, V2ED41007, V2ED41011;

Product 148861025:  Lots V26B71027, V2VKL1008, V26B71029, V26B71015, V26B71006, V26B71026, V2VKL1009, V3TBM1001, V26B71005, V26B71007;

Product 148862025:  Lot V3DC11005;

Product 148881025:  Lots V3TBM1018, V3TBM1019, V3KAW1030, V3BB61011, V3BB61012, V3BB61014, V3BB61016, V3BB61021, V3KAW1012, V2DBE1023, V3BB61025, V3BB71028, V3KAW1011, V3KAY1006, V3KAY1013, V3TBM1011, V2VBL1008, V3BB61023, V3KAW1002, V3KAW1015, V3BB81008, V3KAW1001, V3BB61002, V3KAW1023, V3BB61009, V2VBL1002, V3BB51012, V3BB61004,

V3BB81005, V3BB81025, V3KAW1004, V2VBL1029, V3BB51029, V3BB61008, V2DBF1001, V3TBM1020, V3BB51023, V3BB61020, V3BB81014, V2VBK1030, V2VBL1018, V3BB71002, V3BB71019, V3KAY1008, V2VBL1015, V3KAY1015, V3KAY1016, V2DBF1007, V3BB71014, V3BB51024, V3BB61003, V3KAW1019, V3TBM1006, V3KAW1027, V3BB71021, V2VBL1024, V3KAW1026, V3BB61028, V3BB81020, V26B71003, V26B71011, V26B71034, V3KAY1001, V3TBM1012, V3BB51001, V2VBL1009, V3TBM1005, V3BB61006, V3BB81011, V3BB81023;

Product 148883025:  Lots V2DBG1007, V3BB91022, V2DBG1024, V3BB91020, V18AP1008, V18AP1013, V2DBG1027, V18AP1015, V18AP1019, V33AW1008, V18AP1016, V3BB91002, V3BB91018, V2DBG1013, V2DBG1028, V3WDX1023, V2DBG1017, V18AP1017, V3WDX1001, V18AP1014, V2DBG1019, V3BB91019, V3BB91028, V3BB91012, V33AW1016, V3BB91001, V2DBG1015, V3BB91025, V18AP1020, V18AP1012, V33AW1020, V3BB91011, V18AP1006, V3WDX1008, V3WDX1004, V3BB91026, V33AW1005, V33AW1022, V18AP1009, V2DBG1016,

V3BB91006;

Product 149242025:  Lot V3BLR1005;

Product 149247025:  Lot V3BLS1001;

Product 149256025:  Lots V2LET1006, V2LET1001, V2LET1003, V2LET1005;

Product 149257025:  Lot V3WDL1003;

Product 149265025:  Lot V3BLT1004;

Product 149775988:  Lots V19FK1007, V19FK1003, V19FK1011;

Product 149773025:  Lots V21CG1002, V21CG1018, V2YCS1002, V2YCS1008, V15B91009, V15B91020, V2YCS1001, V15B91003, V15B91018, V15B91030, V1RD31009, V3BLF1012, V2EEB1021, V2YCS1017, V3BLF1033, V1YAT1004, V15B91024, V1RD31017, V21CG1019, V2EEB1006, V2EEB1019, V21CG1032, V2EEB1020, V2EEB1030, V2YCS1006, V3BLF1005, V3BLF1028, VY7GB1023, V21CG1025, V2KBE1038, V3BLF1029, V15B91016, V15B91027, V2YCS1025, V1YAT1005, V21CG1026, V2YCS1003, V21CG1004, V15B91031, V3BLF1013, V3BLF1014, V21CG1016, V3BLF1019, V2KBE1035, V2YCS1015, V3BLF1017, V2EEB1025, V2YCS1009, V3BLF1018, V3BLF1031, V15B91010, V2YCS1013, V2KBE1015, V2KBE1029, V3BLF1021, V3BLF1026, V21CG1022, V2YCS1028, V2EEB1013, V2KBE1016, V2KBE1028, V2EEB1017;

Product 149774025:  Lots V15CA1009, V3CBV1014, V2EEC1005, V2PB21008, V2PB21002, V15CA1012, V1RD41015, V2EEC1011, V2PB21007, V2PB21011, V1RD41004, V2PB21001, V1HD61026, V2PB21014, V3CBV1012, V2PB21019, V1RD41003, V2EEC1010, V2PB21013, V2EEC1012, V2EEC1024, V2EEC1025, V2PB21004, V3CBV1011, V1HD61003, V1HD61005, V2EEC1028, V3CBV1030, V2EEC1008, V3CBV1013, V15CA1006, V15CA1014, V3CBV1003, V3CBV1009, V1HD61014, V1HD61007, V1HD61015, V1RD41001, V1RD41019, V1RD41024, V2EEC1002, V2PB21020, V2PB21021, V15CA1001, V2PB21017, V1HD61016, V1RD41008, V2PB21025, V3CBV1018, V3CBV1026, V2EEC1007, V2PB21005, V2PB21018, V1RD41006, V1RD41007, V1HD61020, V3CBV1027, V3CBV1031, V2EEC1006, V2EEC1029, V1HD61008, V1RD41002, V2EEC1018, V2EEC1017,

V2PB21022, V3CBV1025, V1HD61027, V15CA1008, V1RD41018, V2EEC1001, V2EEC1026, V1RD41022, V15CA1024, V15CA1017, V1HD61024, V1HD61022, V1HD61001, V1RD41009, V1HD61012, V3CBV1022, V15CA1019;

Product 149775025:  Lots VY1HG1020, VY1HG1019, V1HD71007, V2KBF1005, V2PB31010, V2PB31012, V2KBF1012, VY1HG1012, V2KBF1001, V19FG1004, V19FG1006, V2PB31001, VY1HG1002, VY1HG1003, VY1HG1007, V1HD71004, V2KBF1019, V2KBF1022, VY1HG1018, V1HD71003, V1HD71010, V2KBF1017, V2KBF1018, V2PB31015, V2KBF1020, V2PB31016, V1HD71009, V2PB31009, VY1HG1017, V2PB31003, V2KBF1011, VY1HG1011, V2KBF1007, V2KBF1016, V2KBF1009, V2PB31002, V2PB31007, VY1HG1010, V1HD71011, VY1HG1009, VY1HG1015, VY1HG1008, V2PB31005, V1HD71001, V2PB31011, V2PB31013, VY1HG1021,VY1HG1006;

Product 149776025:  Lots V19FM1004, V19FM1008, V19FM1006, V19FM1009, V19FM1003, V19FM1007, V19FM1005;

Product 155118999:  Lot V3WFL1001;

Product 155531000:  Lots V2PBP1005, V2PBP1008, V2PBP1012, V2PBP1007, V2PBP1003;

Product 155532000:  Lots V2VKN1004, V2PBR1003, V2PBR1005, V3LBH1009, V3LBH1003, V2VKN1011, V2VKN1008, V2VKN1010, V2VKN1009, V2VKN1009;

Product 155533000:  Lots V2WEY1011, V2VKM1007, V2VKM1015, V2VKM1017, V2VKM1021, V2VKM1018, V2WEY1014, V2WEY1024, V2WEY1016, V2VKM1014, V2VKM1009, V2VKM1003, V2VKM1024, V2VKM1008, V2VKM1012, V2VKM1010, V2WEY1007, V2VKM1019, V2VKM1013;

Product 155534000:  Lots V2WE11009, V3WDR1012;

Product 155535000:  Lots V3WDS1001, V3WDS1007, V3PDF1010;

Product 155536020:  Lots V3PDG1002, V3PDG1009;

Product 168841025:  Lots V15B71007, V15B71008, V15B71010, V15B71011;

Product 168842025:  Lots V2WE21009, V2WE21009, V2WE21004, V2WE21005, V2WE21010, V2WE21012;

Product 168843025:  Lots V3DC71012, V3DC71001, V3DC71005, V3DC71010;

Product 168851025:  Lots V2NAB1003, V3EBF1007, V2NAB1011, V24AR1002, V3EBF1011, V24AR1005, V24AR1006, V2NAB1001, VY8B1A002, V2NAB1004, V3EBF1004, V2NAB1007, V2NAB1012, V2NAB1009, V2NAB1010, V3EBF1003, V3EBF1009, V3EBF1013, V3LBH1005, V24AR1004, V2NAB1006, V24AR1010;

Product 168852025:  Lots V2NAC1003, V3EBG1006, V3EBG1007, V2NAC1001;

Product 168861025:  Lots V2WE31012, V2WE31002, V2WE31003, V2WE31004, V2WE31001, V2WE31005;

Product 168862025:  Lots V3PDJ1012, V2NAD1010, V2NAD1011, V3PDJ1001, V3PDJ1008, V2NAD1001, V2NAD1008, V2NAD1002, V3PDJ1002, V3PDJ1004;

Product 172280000:  Lot V2LGD1001;

Product 177982025:  Lots V16CH1002, V1DKK1002, V1DKK1029, V16CH1005, V16CH1004, V16CH1001, V16CH1003, V1WMK1002, VX8LK1001;

Product 177983025:  Lots V2VA21007, V2VA21010, V2VA21012, V1DBN1014, V2VA21001, V1DBN1007, V1DBN1002, V1DBN1003, V1DBN1012, V1DBN1004, V1DBN1016, V2VA21002, V2VA21003, V1DBN1009, V2VA21009, V2VA21011, V2VA21019, V2VA21014, V1DBN1008, V1DBN1010;

Product 177984025:  Lots V2CBT1018, V2CBT1030, V2KBC1015, V2CBT1014, V2CBT1015, V2KBC1004, V2KBC1005, V2KBC1012, V2KBC1013, V2KBC1020, V1WML1001, V1WML1009, V2KBC1003, V2KBC1019, V2KBC1008, V2KBC1002, V2CBT1024, V2KBC1010, V2CBT1013, V2CBT1019, V1WML1008, V2CBT1001, V2CBT1005, V2CBT1004, V2CBT1025, V2KBC1007, V1WML1007, V2CBT1002, V2KBC1011, V2CBT1010, V2CBT1017, V2CBT1022, V2KBC1001, V2KBC1009;

Product 177985025:  Lots V1DKK1025, V2CBV1002, VY8BV1002, VY8BV1008, V1DKK1012, VY8BV1005, V1DKK1005, V1WMK1005, V1WMK1007, V1WMK1010, VX8LK1006, VY8BV1019, VX8LK1009, V1WMK1004, V1DKK1010, V1DKK1011, V1DKK1030, V1DKK1017, VY8BV1014, V2PBH1006, V1DKK1027, VX8LK1008, V1DKK1008, VX8LK1007, V2CBV1010, VY8BV1010, VY8BV1006, VY8BV1015, VX8LK1003, VY8BV1009, V2CBV1008, V1DKK1024, VX8LK1019, V1DKK1022, VX8LK1005, VY8BV1001, V1DKK1009, V2PBH1004, V1DKK1007, VY8BV1011, V1DKK1023;

Product 177986025:  Lots V2DA51005, V2DA51002, VW4ES1005, V2DA51001, VW4ES1009;

Product 195641025:  Lots V3PDK1005, V3PDK1007, V3PDK1001;

Product 195651025:  Lots V26B41006, V3PDL1001, V26B41007, V26B41005, V3PDL1006, V26B41003, V3PDL1003, V2WE41001, V3PDL1004, V2WE41006;

Product 195653025:  Lots V2DA11004, V3PDM1004, V2DA11005;

Product 195662025:  Lots V3PEP1005, V3PEP1009, V3PEP10013.

RECALLING FIRM/MANUFACTURER Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERECE Approx. 2,610 devices.

DISTRIBUTION Nationwide, Canada, Brazil and England.

 

WEEK ENDING JANUARY 19

 

PRODUCT A.NextStitch Cardiovascular Valve Suture, Sterile. Labeled in part: "NEXTSTITCH Cardiovascular Valve Suture TEVDEK II Braided PTFE Impregnated Polyester STERILE***" (6-Pack and 9-Pack Configurations) See Code Section for Product Codes and Lot Numbers

B.Sutures:Deklene, Polydek, Polyene, Silk, Tevdek; and Pledgets Sutures in various Combination of numbers of sutures and needles.

74 Product Codes- Refer to Code Section

CODE NextStitch Cardiovascular Valve Suture 6-Pack and 9-Pack Configurations NextStitch(tm) Cardiovascular Valve Suture

Product Code                        Lot Number                           Product Code                        Lot Number

EG79-105C6                           416480                                    EH7-100C9                             442014

EG79-105C6                            436937                                   EH7-100C9                             447758

EG79-105C6                                        436962                                                 EH7-100C9                                           463186

EG79-105C6                           436963                                    EH7-100C9                             474139

EG79-105C6                           438589                                    EH79-100C6                           454675

EG79-105C6                           443688                                    EH79-100C6                           472308

EG79-105C6                           451644                                    EH79-100C6                           475397

EG79-105C6                           456236                                    EH79-100C9                           454672

EG79-105C6                           457722                                    EH79-100C9                           475394

EG79-105C6                           463191                                    E7-103C9                                474142

EG79-105C6                           466017                                    E79-104C9                              413242V

EG79-105C6                           474591                                    E79-104C9                              416440

EG79-105C9                           438590                                    E79-104C9                              451648

EG79-105C9                           443683                                    E79-104C9                              458929

EG79-105C9                           460297                                    E79-104C9                              458930

EG79-105C9                           471540                                    E79-104C9                              463696

EG79-105C9                           474143                                    E79-104C9                              467259

EG79-105C9                           474592                                    E79-105C9                              413243V

EG79-107C9                           463188                                    E79-105C9                              416442

EG79-108C9                           442018                                    E79-105C9                              454673

EG79-108C9                           457684                                    E79-105C9                              461993

EG79-112C9                           456241                                    E79-105C9                              461994

EG79-112C9                           456253                                    E79-105C9                              463184

EG79-114C6                           464187                                    E79-105C9                              463185

EG79-114C6                           470165                                    E79-108C9                              474141

EG79-114C9                           464188                                    EB79-105C6                           413274V

EG79-114C9                           470166                                    EB79-105C6                           416441

EH7-100C6                             454674                                    EB79-105C6                           447787

EH7-100C6                             461995                                    EB79-105C6                           461996

EH7-100C6                             467260                                    EB79-105C6                           475398

79-104C9K                             492361                                    EG7-113C9                             463190

EB79-100C6                           411366V                                 E79-111C9                              411384V

EB79-100C6                           416438                                    E79-111C9                              416439

EB79-100C6                           447779                                    E79-111C9                              451647

EB79-100C6                           451641                                    E79-111C9                              460295

EB79-100C6                           460298                                    E79-111C9                              463695

EB79-100C6                           463694                                    E79-111C9                              467258

EB79-100C6                           466014                                    E79-111C9                              472319

EC7-100C9                             420296                                    E79-111C9                              477209

EC7-100C9                             423250                                    E79-111C9                              479026

EC79-100C9                           416479                                    EG79-104C9                           442017

EC79-100C9                           458925                                    EG79-104C9                           458931

EG7-106C6                             464768                                    EG79-104C9                           460296

EG7-106C6                             464769                                    EG79-104C9                           474823

EG7-106C6                             466012                                    7-106C9K                               483498

EG7-106C6                             471542                                    7-106C9K                               496851

EG7-106C9                             442015                                    7-113C6K                               478430

EG7-106C9                             447772                                    7-113C9K                               492359

EG7-106C9                             474140                                    G79-114C6K                          483454

EG7-113C6                             472312                                    G79-114C6K                          488454

EG7-113C6                             479025                                    G79-114C6K                          506534

EG79-100C6                           416478                                    G79-114C9K                          483455

EG79-100C6                           436936                                    G79-114C9K                          488455

EG79-100C6                           442019                                    G79-114C9K                          497925

EG79-100C9                           438039                                    G79-114C9K                          506535

EG79-100C9                           442016                                    G79-114C9K                          507773

EG79-100C9                           456252                                    79-100C9K                             492360

EG79-104C6                           447786                                    H7-100C6K                            486084

EG79-104C6                           451642                                    H7-100C6K                            488457

EG79-104C6                           458932                                    H7-100C6K                            495410

EG79-104C6                           458934                                    79-104C6K                             489810

EG79-104C6                           464770                                    79-104C6K                             507949

EG79-104C6                           466015                                    H7-100C9K                            486098

EG79-104C6                           474821                                    H7-100C9K                            492350

G79-107C6K                          478431                                    H79-100C6K                          482103

H79-100C9K                          483459                                    G7-113C9K                            483449

H79-100C9K                          496850                                    G7-113C9K                            484917

79-105C9K                             486093                                    G7-113C9K                            486745

79-112C9K                             475324                                    G7-113C9K                            493391

N7-100C6K07                        503849                                    G7-113C6K                            483448

N7-100C9K07                        503844                                    G7-113C6K                            486742

N7-106C6K07                        503852                                    G7-113C6K                            499198

N7-106C9K07                        503848                                    G7-106C9K                            480494

N7-113C6K07                        503850                                    G7-106C9K                            486744

N7-113C9K                            503695                                    G7-106C9K                            493390

N7-113C9K07                        503845                                    G7-106C9K                            496845

N7-113C9K07                        503846                                    G7-106C9K                            496846

N79-105C6K                          488458                                    G7-106C6K                            486741

N79-114C6K07                      503851                                    G7-100C6K                            490444

N79-114C9K07                      503847                                    G7-100C6K                            496847

6-100C9K                               497408                                    G7-100C9K                            486095

6-113C9K                               497409                                    G79-105C9K                          480496

6-113C9K                               505585                                    G79-105C9K                          488450

7-103C6K                               497932                                    G79-104C6K                          486750

7-103C9K                               486091R                                 G79-100C9K                          482104

7-103C9K                               492358                                    G79-100C6K                          482102

7-106C6K                               483500                                    G79-105C9K                          508232

G79-105C6K                          480495 

G79-105C6K                          488448         

G79-105C6K                          488449         

G79-105C6K                          497924         

G79-104C9K                          482106         

G79-104C9K                          493388         

G79-104C9K                          496848         

G79-104C9K                          496849         

Sutures:Deklene, Polydek, Polyene, Silk, Tevdek;and Pledgets

Extended Recall:Sutures in various Combination of numbers of  sutures and needles.

Suture Type/Part number                   Lot Number   Description

Deklene ED-7063M2A                         277502 DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  281786  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  290167  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  295887  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  309343  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  313321  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  315685  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  317033  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  320992  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  340434  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  344296  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  348331  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  352014  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  362412  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  366010  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  374313  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  377544  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene                                                  392445  DEK BL MF 7-0 XT-6 2N 2X75CM

Deklene ED-7070M1A                         277505  DEK BL MF 6-0 XT-6 2N 75CM

Deklene                                                  283635  DEK BL MF 6-0 XT-6 2N 75CM

Deklene                                                  290745  DEK BL MF 6-0 XT-6 2N 75CM

Deklene                                                  297336  DEK BL MF 6-0 XT-6 2N 75CM

Deklene                                                  484819  DEK BL MF 6-0 XT-6 2N 75CM

Deklene                                                  323464  DEK BL MF 6-0 XT-6 2N 4X75CM

Deklene                                                  433205  DEK BL MF 6-0 XT-6 2N 4X75CM

Deklene                                                  277503  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  281379  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  288846  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  290168  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  297337  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  316605  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  320994  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  333969  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  335795  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  337253  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  337705  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  369664  DEK BL MF 6-0 XT-1 2N 75CM

Deklene                                                  396715  DEK BL MF 6-0 XT-1 2N 75CM

Deklene ED-7310M2                            347964  DEK BL MF 7-0 ST6 2N 2X60CM

Deklene                                                  437199  DEK BL MF 7-0 ST6 2N 2X60CM

Deklene ED-7414M1B                         415958  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene                                                  451756  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene                                                  474291  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene                                                  491919  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene                                                  499273  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene                                                  501459  DEK BL MF 6-0 EZ-1 2N 1X75CM

Deklene ED-7414M4                            308522  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  363857  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  387280  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  419202  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  451757  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  462610R DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene                                                  480039  DEK BL MF 6-0 EZ-1 2N 4X75CM

Deklene ED-7505M1A                         289233  DEK BL MF 8-0 XT-6.5 2N 1X24"

Deklene                                                  303625  DEK BL MF 8-0 XT-6.5 2N 1X24"

Deklene                                                  317320  DEK BL MF 8-0 XT-6.5 2N 1X24"

Deklene                                                  321002  DEK BL MF 8-0 XT-6.5 2N 1X24"

Deklene ED-7505M1B                         421084  DEK BL MF 8-0 XT-6.5 2N 1X24"

Deklene ED-7506M4                            273190  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  287109  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  290720  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  304412  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  317321  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  321003  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  323300  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  325291  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  330579  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  358503  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  363943  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  369267  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  380045  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  386639  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  399098  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  407444  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  410885  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  414654  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  452182  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  455711  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  460590R DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  469042  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene                                                  504286  DEK BL MF 7-0 XT-6.5 2N 4X60CM

Deklene ED-7507M2                            377613  DEK BL MF 7-0 XT-6.5 2N 2X75CM

Deklene                                                  387281  DEK BL MF 7-0 XT-6.5 2N 2X75CM

Deklene                                                  476888  DEK BL MF 7-0 XT-6.5 2N 2X75CM

Deklene ED-5007M1B                         438883  DEK BL MF 6-0 XT-6 2N 1X60CM

Deklene ED-5007M4A                         303626  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene                                                  328421  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene                                                  351660  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene                                                  376473  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene                                                  456231  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene                                                  501396  DEK BL MF 6-0 XT6 2N 4X60CM

Deklene ED-6263M1                            285411  DEK BL MF 8-0 XT-7 2N 1X75CM

Deklene                                                  311890  DEK BL MF 8-0 XT-7 2N 1X75CM

Deklene                                                  476885  DEK BL MF 8-0 XT-7 2N 1X75CM

Deklene ED-6290M1                            291536  DEK BL MF 8-0 XT-6.5 2N 1X75CM

Deklene ED-6456M1B                         415954  DEK BL MF 7-0 EZ-6 2N 1X75CM

Deklene                                                  419207  DEK BL MF 6-0 EZ-6 2N 1X75CM

Deklene ED-6459M1                            380613  DEK BL MF 6-0 EZ-6 2N 1X75CM

Deklene ED-7004M1A                         391473  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene                                                  434408  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene ED-7004M1B                         415955  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene                                                  451755  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene                                                  499272  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene                                                  501397  DEK BL MF 7-0 XT-6 2N 1X60CM

Deklene ED-7004M4A                         296300  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  324313  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  337252  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  346462  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  358051  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  384707  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  390461  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  401973  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  409651  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  415981  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  421896  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  427862  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  441825  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  444637  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  444971  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  447320  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  474305  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene                                                  476428  DEK BL MF 7-0 XT6 2N 4X60CM

Deklene ED-7015M4A                         309603  DEK BL MF 7-0 XT-1 2N 4X60CM

Deklene                                                  329833  DEK BL MF 7-0 XT-1 2N 4X60CM

Deklene                                                  377609  DEK BL MF 7-0 XT-1 2N 4X60CM

Deklene ED-7018M1A                         377656  DEK BL MF 5-0 XT-1 2N 1X75CM

Deklene ED-7018M1B                         415956  DEK BL MF 5-0 XT-1 2N 1X75CM

Deklene ED-7018M2A                         336143  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  347981  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  349538  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  387279  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  403685  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  447324  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  473023  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene                                                  501398  DEK BL MF 5-0 XT-1 2N 2X75CM

Deklene ED-7018M4A                         288420  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  317032  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  340432  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  344290  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  358912  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  364669  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  371494  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  389636  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  405891  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  414652  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  424803  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  478236  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene                                                  482530  DEK BL MF 5-0 XT-1 2N 30"X4

Deklene ED-7060M4A                         293520  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  304220  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  308791  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  310760  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  318572  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  342990  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  346461  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  369264  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  406110  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  455246  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  462609  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene                                                  504211  DEK BL MF 5-0 XT-1 2N 4X60CM

Deklene ED-7061M1A                         391476  DEK BL MF 5-0 XT-1 2N 1X90CM

Deklene                                                  466250  DEK BL MF 5-0 XT-1 2N 1X90CM

Deklene ED-7063M1A                         275051  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  281785  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  288421  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  290744  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  297335  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  323297  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  330260  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  335793  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  337704  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  344294  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  346463  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  351194  DEK BL MF 7-0 XT-6 2N 75CM

Deklene                                                  354695  DEK BL MF 7-0 XT-6 2N 75CM

Deklene ED-7076M2A                         277504  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  281787  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  295888  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  297338  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  318997  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  322208  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  328422  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  333970  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  340442  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  353738  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  364670  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  368399  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  378521  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  385873  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  387347  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  390956  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  397344  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene                                                  401000  DEK BL MF 6-0 XT-1 2N 2X75CM

Deklene ED-7076M4A                         273413  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  288187  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  298545  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  304213  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  310772  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  315686  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  317319  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  320995  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  328424  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  341346  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  348332  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  355793  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  366025  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  374315  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  378522  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  382100  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  406084  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  413262  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  418224  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  424805  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  444638  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene                                                  472534  DEK BL MF 6-0 XT-1 2N 4X75CM

Deklene ED-7504M2                            271469  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  278091  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  287108  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  290401  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  304215  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  306920  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  309925  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  330578  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  333972  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  337706  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  342991  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  351195  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  355795  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  358053  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  366758  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  374217  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  376767  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  424792  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  427767  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  429860  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  435885  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  450904  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  460589  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  469041  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  471414  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  475309  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  480098  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  481011  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  486065  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene                                                  488853  DEK BL MF 8-0 XT-7 2N 2X60CM

Deklene ED-7505M2A                         290735  DEK BL MF 8-0 XT-6.5 2N 2X60CM

Deklene                                                  380641  DEK BL MF 8-0 XT-6.5 2N 2X60CM

Deklene ED-7506M2                            271442  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  278079  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  288847  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  293523  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  295532  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  303636  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  307950  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  321721  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  326141  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  331663  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  337588  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  357710  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  365654  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  369266  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  380044  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  386638  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  401164  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  480099  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Deklene                                                  488854  DEK BL MF 7-0 XT-6.5 2N 2X60CM

Polydek EXRN6-5089M4                    276419  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  347980  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  377649  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  387230  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  435381  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  440105  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  463493  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  493463  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek                                                  499274  POL GN BR 3-0 DLX30 1RN 4X45CM

Polydek EXRN6-5184M6                    276422  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  298546  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  304212  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  358931  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  364559  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  366030  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  385878  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  391531  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  395822  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  399085  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  399787  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  474310  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  482301  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  486054  POL GN BR 0 DS30 1RN 6X45CM

Polydek                                                  500443  POL GN BR 0 DS30 1RN 6X45CM

Polydek EXRN6-5088M4                    275411  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  297216  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  327656  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  353178  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  358065  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  380437  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  402174  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  406977  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  408449  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  439705  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  463492  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  473752  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  478046  POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek                                                  494933R POL GN BR 2-0 DLX30 1RN 4X45CM

Polydek ERN6-6493M8                       377633  POL GN BR 3-0 DLX30 1RN 8X45CM

Polydek                                                  398642  POL GN BR 3-0 DLX30 1RN 8X45CM

Polydek E6-5146M6                             275240  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  285083  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  290177  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  297218  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  308246  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  310188  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  316206  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  320677  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  321783  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  327577  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  336904  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  344400  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  353364  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  354732  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  360477  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  400021  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  410606  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  414650  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  421778  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  424800  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  434521  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  438024  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  448347  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  460585  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  463030  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  465949  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  481242  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  493665  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  499673  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  502393  POL GN BR 0 DS30 1N 6X45CM

Polydek                                                  504681  POL GN BR 0 DS30 1N 6X45CM

Polylene E13-5524M4                          295873  PLENE GN 2-0 HR22+1RN4X45CM

Polylene E13-6492M4                          377639  PLENE GN 3-0 DS18 1RN 4X45CM

Polylene E13-6835M8                          309583  PLENE GN 4-0 HR17+1RN 8X45CM

Polylene                                                 319813  PLENE GN 4-0 HR17+1RN 8X45CM

Silk ERN-5689M4                                 309580  SLK BK BR 4-0 HR12+1RN 4X45CM

Silk ES-9028M5                                     287111  SLK BK BR 3 5X45CM

Silk                                                          290710  SLK BK BR 3 5X45CM

Silk EXRNS-5721M8A                         276411  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          280553  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          297217  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          308820  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          313290  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          321001R SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          327652  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          333975  SLK BK BR 0 HR30 1RN 8X45CM

Silk                                                          364548  SLK BK BR 0 HR30 1RN 8X45CM

Silk EXS-9028M5                                  276423  SLK BK BR 3 5X45CM

Silk                                                          293548  SLK BK BR 3 5X45CM

Silk EXRNS-6131M8                            276410  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          284753  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          300018  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          317038  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          327654  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          328425  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          341378  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          344354  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          356951  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          366029  SLK BK BR 3-0 HR22 1RN 8X45CM

Silk                                                          374304  SLK BK BR 3-0 HR22 1RN 8X45CM

Tevdek  E7975-0052                             493374  TEV GN BR 5-0 KT-1 1N 18"

Tevdek  E7975-0054                             493375  TEV GN BR 5-0 KT-2 1N 18"

Tevdek                                                   497630  TEV GN BR 5-0 KT-2 1N 18"

Tevdek                                                   505055  TEV GN BR 5-0 KT-2 1N 18"

Tevdek                                                   508759  TEV GN BR 5-0 KT-2 1N 18"

Tevdek  E7975-0056                             489615  TEV GN BR 6-0 KT-1 1N 18"

Tevdek  E7975-0063                             491831  TEV GN BR 4-0 KT-1/KT-2 2N 36"

Tevdek  E7975-0065                             491978  TEV GN BR 5-0 KT-1/KT-2 2N 36"

Tevdek                                                   497683  TEV GN BR 5-0 KT-1/KT-2 2N 36"

Tevdek  E7RN-6384M4                       333486  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   385284  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   389787  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   399284  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   401241  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   443808  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   447318  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   489777  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   491133  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek                                                   504217  TEV GN BR 2-0 HR22+ 1RN 4X45CM

Tevdek  E7RN-4834M8                       310962  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   393040  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   401091  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   411813  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   423561  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   424453  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   463499  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   480658  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek                                                   494520  TEV GN 4-0 HR12+ 1RN 8X45CM

Tevdek  E7RN-5336M8                       303180  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   303371  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   306328  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   308823  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   310804  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   311616  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   318978  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   324307  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   330254  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   427772  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek                                                   491345  TEV GN 4-0 HR17 1RN 8X45CM

Tevdek  E7RN-5697M8                       293539  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   297332  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   306112  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   308824  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   328432  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   333985  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   343187  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   369304  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   385299  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   388520  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   398011  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   448350  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   463036  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   466513  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   472819  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   491346  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek                                                   500442  TEV GN 2-0 HR26+ 1RN 8X45CM

Tevdek  E7RN-5698M8                       326927  TEV GN BR 0 HR26+ 1N 8X45CM

Tevdek                                                   366591  TEV GN BR 0 HR26+ 1N 8X45CM

Tevdek                                                   385280  TEV GN BR 0 HR26+ 1N 8X45CM

Tevdek                                                   467352  TEV GN BR 0 HR26+ 1N 8X45CM

Tevdek                                                   480037  TEV GN BR 0 HR26+ 1N 8X45CM

Tevdek  ERN7-6071M8                       306123  TEV GN BR 3-0 HR17+ 1RN 8X45CM

Tevdek                                                   308819  TEV GN BR 3-0 HR17+ 1RN 8X45CM

Tevdek                                                   309933  TEV GN BR 3-0 HR17+ 1RN 8X45CM

Tevdek                                                   320998  TEV GN BR 3-0 HR17+ 1RN 8X45CM

Tevdek                                                   323303  TEV GN BR 3-0 HR17+ 1RN 8X45CM

Tevdek  ERN7-6486M8                       503470  TEV GN BR 3-0 HR12 1RN 8X45CM

Tevdek  ERN7-6518M4                       402724  TEV GN BR 3-0 HR22+ 1RN 4X45CM

Tevdek                                                   451322  TEV GN BR 3-0 HR22+ 1RN 4X45CM

Tevdek                                                   462605  TEV GN BR 3-0 HR22+ 1RN 4X45CM

Tevdek                                                   463039  TEV GN BR 3-0 HR22+ 1RN 4X45CM

Tevdek                                                   470160  TEV GN BR 3-0 HR22+ 1RN 4X45CM

Tevdek  E7-5793M4                             346866  TEV GN 4-0 DSM19(RE2)1N 4X45CM

Tevdek                                                   415959  TEV GN 4-0 DSM19(RE2)1N 4X45CM

Tevdek  ERN7-5113M8                       278094  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   284407  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   296304  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   303386  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   311618  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   315283  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   318986  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   328054  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   337550  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   344333  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   351674  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   354415  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   360171  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   371477  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   374986  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   390473  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   401975  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   409141  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   410602  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   412850  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   422128  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   479594  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   488259  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   494524  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek                                                   505975  TEV GN BR 3-0 HR22+ 1RN 8X45CM

Tevdek  E7-6344GWM8                      326022  TEV G/W 2-0 DR23 2N 8X75CM

Tevdek                                                   312431  TEV G/W 2-0 DR23 2N 8X75CM

Tevdek                                                   319570  TEV G/W 2-0 DR23 2N 8X75CM

Tevdek  EV7-6471GWM10                 500448  TEV G/W 2-0 KC2 2N 10X75CM PSM

Tevdek  EV7-1271GWM10                 298188  EXH USE EV7-1271GWM10

Tevdek  EG7-5649GWM16                 311297  TEV G/W2-0  HRT17 2N16X75CMPFM

Tevdek                                                   319569  TEV G/W2-0  HRT17 2N16X75CMPFM

Tevdek   ERN7-5741M8                      275395  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   276400  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   300016  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   321444  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   321731  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   329851  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   333169  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   336513  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   337551  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   347551  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   353174  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   357960  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   361316  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   371478  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   384714  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   394868  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tvdek                                                     399598  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevek                                                     410601  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevek                                                     414645  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdk                                                     462269  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevde                                                     472537  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   478045  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   486067  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   493122  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   499658  TEV GN BR 2-0 HRT20 1RN 8X45CM

Tevdek                                                   503038  TEV GN BR 2-0 HRT20 1RN 8X45CM

Pledget Part Number                            Lot Number      Description

Pledget EX-5145                                   322561  PLED SFT 6"X5/16"X1/16" X2

Pledget                                                   352280  PLED SFT 6"X5/16"X1/16" X2

Pledget                                                   401350  PLED SFT 6"X5/16"X1/16" X2

Pledget                                                   443799  PLED SFT 6"X5/16"X1/16" X2

Pledget EX-6499                                   388061  PLED INT 1/2" X4" X1/16" X1

Pledget                                                   409461  PLED INT 1/2" X4" X1/16" X1

Pledget                                                   486051  PLED INT 1/2" X4" X1/16" X1

Pledget                                                   494480  PLED INT 1/2" X4" X1/16" X1

Pledget EX-6500                                   399607  PLED INT 1/2"X6"1/16"X1

Pledget                                                   409462  PLED INT 1/2"X6"1/16"X1

Pledget                                                   429359  PLED INT 1/2"X6"1/16"X1

Pledget                                                   455247  PLED INT 1/2"X6"1/16"X1

Pledget                                                   467353  PLED INT 1/2"X6"1/16"X1

Pledget                                                   480040  PLED INT 1/2"X6"1/16"X1

Pledget                                                   493452  PLED INT 1/2"X6"1/16"X1

RECALLING FIRM/MANUFACTURER Genzyme Biosurgery a div. of Genzyme Corporation Fall River, MA

REASON Sterility of the device may be compromised due to breach in the pouch seal.

VOLUME OF PRODUCT IN COMMERCE 14,179 pieces

DISTRIBUTION Nationwide and International

 

PRODUCT Optetrak 3-Peg Patella, Size 29mm and Optetrak 3-Peg Patella, Size 32 mm

CODE Catalog Number 200-02-29, serial numbers 240816 through 0240870 and catalog number 200-02-32, serial numbers 0240761 through 0240815.

RECALLING FIRM/MANUFACTURER Exactech, Inc. Gainesville, FL

REASON Mislabled with incorrect device size.

VOLUME OF PRODUCT IN COMMERCE 69

DISTRIBUTION Nationwide.

 

PRODUCT Straumann Endosseous Dental Implant Esthetic Plus Solid Screw labeled as:  Strauman Solid Screw Implant 0.48 mm, 6.0 mm PLUS

(endosseous length 7.0 mm), Ti. Sterile. 

CODE Catalog Number: 043.240S Lot Number: 1007 Exp. Date: 2005-03

RECALLING FIRM/MANUFACTURER Recalling Firm: The Straumann Co. Waltham, MA

Manufacturer:  Institut Strauman AG Waldenburg, SWITZERLAND, 

REASON Some Dental Implants mislabeled as Wide Neck Implant on the back of the outside packaging

VOLUME OF PRODUCT IN COMMERCE 191 implants.

DISTRIBUTION Nationwide

 

PRODUCT E.CAM Ball Screws, a component of the ball screw yoke assemblies of the E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; The ball screws were used to make the following assemblies

a) part 5208587 - Right for Upper Yoke Assembly (Pivot Side)

b) part 5208892 - Right for Lower Yoke Assembly (Clutch Side)

c) part 5208884 - Left for Uppper Yoke Assembly (Clutch Side)

d) part 5208900 - Left for Lower Yoke Assembly (Pivot Side)

CODE Ball screw assemblies, part numbers 5208587, 5208892, 5208884 and 5208900 are components in the following cameras:

Model 4380221 - E.CAM Gantry Dual Head Variable, serial numbers 0005 to 1215

Model 5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 to 3141, 4001 to 4111

Model 5977066 - E.CAM Gantry Dual Head Variable, serial numbers 4100 to 4178

Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 to 4016

Model 5977074 - E.CAM Gantry Single Head, serial numbers 4001 to 4031

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

REASON E.Cam radial drive ball screw may fail

VOLUME OF PRODUCT IN COMMERCE 764 cameras.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT E.CAM PHS beds used with the E.CAM Emission Imaging Computed TOmography Systems used for all common nuclear medicine procedures. 

CODE Model 4366618, serial numbers 0006 through 2034; Model 4381088, serial numbers 0002 through 2029

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

REASON Acme screw may fail and cause front or rear of bed to fall during use

VOLUME OF PRODUCT IN COMMERCE 181 units.

DISTRIBUTION Nationwide and International.

 

PRODUCT Bulb Irrigation Trays, 20 trays per case; labeled under the following labels:

a) Gent-L-Kare Irrigation Tray with 60 cc Bulb Syringe, catalog 4092 Premium Plastics Inc., Chicago, IL

b) Bulb Irrigation Tray, catalog 750170, Distributed by C.R. Bard, Inc., Covington, GA 30014

c) Bardia Bulb Irrigation Tray, catalog 802050, Distributed by C.R. Bard, Inc., Covington, GA 30014

CODE catalog #4092, lots beginning with "MF", "MH","N", "P", "R", "S", "T" and "U". catalog #750170 and 802050 - all lots

RECALLING FIRM/MANUFACTURER Premium Plastics, INC. Chicago, IL

REASON Holes may develop in the trays, compromising the sterility of the kits

VOLUME OF PRODUCT IN COMMERCE 829,960 trays

DISTRIBUTION Nationwide, Canada, and Saudi Arabia

 

PRODUCT Procedural Trays, and Kits containing Procedural Trays, 1) Johnson & Johnson Medical Procedural Trays for BIOVUE

Peripherally Inserted Family of Catheters;  and

2) Kits consisting of: (a) Johnson & Johnson BIOVUE Peripherally Inserted Central Catheter (PICC), or Midline Catheter, both with

OCRILON II Polyurethane; (b) PROTECTIV Safety Introducer System; and (c) Procedural Tray.

 

KITS with Peripherally Inserted Central Catheter (PICC):

Product     Description

#97901     PICC - Dual Lumen Procedure Kit 16 G /5 Fr

#97907     PICC - Dual Lumen Procedure Kit 18 G /4 Fr   

#97910     PICC - Single Lumen Procedure Kit 18 G /4 Fr   

#97913     PICC - Single Lumen Procedure Kit 20 G /3 Fr

#97916     PICC - Single Lumen Procedure Kit 24 G /2 Fr

KITS with Peripherally Inserted Midline Catheter:

Product     Description

#97919     Midline - Dual Lumen Procedure Kit 18 G/ 4 Fr

#97922     Midline - Single Lumen Procedure Kit 18 G/ 4 Fr

#97925     Midline - Single Lumen Procedure Kit 20 G/ 3 Fr,

PROCEDURE TRAYS:

Product    Description

#97993     Procedure tray for use with BIOVUE PICC's and Midlines 'Latex-Free'.

#97994     Procedure tray for use with BIOVUE PICC's and Midlines.

CODE All packaging lot numbers, still within their expiry period, are affected by this recall.

RECALLING FIRM/MANUFACTURER Recalling Firm: ETHICON ENDO-SURGERY, INC. CINCINNATI, OH

Manufacturer:  Johnson & Johnson Medical, Cincinnati, OH

REASON Sterility of the device may be compromised as evidenced by a loss of package integrity.

VOLUME OF PRODUCT IN COMMERCE 12,305

DISTRIBUTION Nationwide.

 

PRODUCT MediSense Precision PCx Blood Glucose Test Strips for use with the Precision G, Precision PCx or i-STAT 1 Analyzer

Blood Glucose Systems. 

CODE Medisense Precision PCx Blood Glucose Test Strips

Part Number: 98849-12 (100 count) Europe, Middle East Dist.

Part Number: 98757-12 (100 count) USA, Canada, Australia, New Zealand, Southeast Asia

Part Number: 99565-01 (100 count) USA Distribution

Lot No.

126425, 127595, 127715, 127745, 127775, 127785, 127875, 127885, 127965, 127975, 127995, 128155, 128175, 128345, 128355, 128455, 128545, 128565, 128575, 128615, 128625, 128635, 128695, 128845, 128925, 128935, 129085, 129095, 129115, 129135, 129145, 129155, 129265, 129295, 129365, 129455, 129525, 129535, 129565, 128675, 128465, 129555, 129565, 127145, 127575, 129055, 129555, 128675

RECALLING FIRM/MANUFACTURER Recalling Firm:  Abbott Laboratories  Medisense Products Bedford, MA

Manufacturer:  Medisense United Kingdom, Limited, Abingdon, United Kingdom.

REASON Blood Glucose Test Strips Control Solution ranges are incorrectly assigned

VOLUME OF PRODUCT IN COMMERCE 235,905.

DISTRIBUTION Nationwide and worldwide.

 

PRODUCT Integris Monitor Arm, Product P997

CODE Integris Monitor Arm, Product number P997

RECALLING FIRM/MANUFACTURER Hill-Rom CO. Batesville, IN

REASON Monitor arm may loosen and fall or drop the monitor

VOLUME OF PRODUCT IN COMMERCE 2,970.

DISTRIBUTION Nationwide.

 

PRODUCT Insight Technologies Instruments Keratome Blade, Disposable and Sterile. For use with the Becton Dickinson  Model BD K-3000

Microkeratome System.

CODE Insight Technologies Instruments Disposable Keratome Blade, Sterile Reference: 300300

Lot numbers: M20186, M20198, M20219, M20223, M20240, M20527, M20282, M21009

RECALLING FIRM/MANUFACTURER Recalling Firm: BD [Becton Dickinson] Ophthalmic  Systems Waltham, MA

Manufacturer: Micro Specialties, Inc. Milford, CT.

REASON Kerotome Blade may fail to oscillate properly and cause corneal abrasion

VOLUME OF PRODUCT IN COMMERCE 3270

DISTRIBUTION AK, CA, IL, NY, PA, WA.

 

PRODUCT Prisma Dialysis System Control Unit, Catalog No. 018080101, Serial Numbers 963111 thru 963143, and 963194 thru 963530.

CODE Prisma Control Unit, Catalog No. 018080101, Serial numbers 963111 to 963143, 963194 to 963530.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Gambro Renal Products Lakewood, CO

Manufacturer: GAMBRO Dasco S.p.A. I-41036 Medolla (MO), IT

REASON Displayed value of "actual patient fluid removal" can be incorrect

VOLUME OF PRODUCT IN COMMERCE 161

DISTRIBUTION Nationwide.

 

PRODUCT 2.17 mm Coronary TEC Catheter. Model C102165. 

CODE Lot F0122702

RECALLING FIRM/MANUFACTURER Interventional Technologies, INC., San Diego, CA

REASON Mislabeled with smaller size.

VOLUME OF PRODUCT IN COMMERCE 19

DISTRIBUTION CA, OH, PA, NY, IL, MO, NC, FL.

 

PRODUCT Human Heart Valves, processed and frozen, for transplantation

CODES:  99-1311HV-02, 98-1532HV-02, 98-0476HV-01, 98-0476HV-02, 98-1532HV-01, 98-0132HV-01, 98-0132HV-02, 98-1302HV-01,

99-1311HV-01

RECALLING FIRM/MANUFACTURER Lifenet, Virginia Beach, VA

REASON Donor of tissues for transplantation was not properly assessed for suitability.

VOLUME OF PRODUCT IN COMMERCE 9 heart valves

DISTRIBUTION MA, VA, GA, PA, ME and TX.

 

PRODUCT Dissecting Tools, a round, fluted dissecting accessory tool to the Midas Rex III System and the Midas Rex Classic System, which are both pneumatic drill systems for use in surgery,

CODE Product code G8-340 Dissecting Tool, Lot number Q6400.

RECALLING FIRM/MANUFACTURER Midas Rex, L.P. Fort Worth, TX

REASON Product mix-up.

VOLUME OF PRODUCT IN COMMERCE 50

DISTRIBUTION Nationwide and South Africa

 

PRODUCT Architect Total T4 calibrators, list 6C49-01; for the calibration of the Architect i System when used for the quantitative

determination of thyroxine (Total T4) in human serum and plasma; Abbott Laboratories, Abbott Park, IL 60064.

CODE list 6C49-01, lot 71756Q100

RECALLING FIRM/MANUFACTURER Recalling Firm:  Abbott Laboratories, INC. Abbott Park, IL

Manufacturer:  Abbott Health Products, INC. Barceloneta, Puerto Rico

REASON 9% negative bias in patient results

VOLUME OF PRODUCT IN COMMERCE  212 kits.

DISTRIBUTION Nationwide and International

 

PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies.

CODE Autoperfusion Software, versions 1.0 and 1.1 installed on ICON P and ICON AP workstations

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

REASON The software did not save oblique data correctly

VOLUME OF PRODUCT IN COMMERCE 211

DISTRIBUTION Nationwide and Intenationally.

 

PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies.

CODE Autoperfusion Software, version 1.2 installed on ICON P and ICON AP workstations.

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

REASON Rest/stress datasets are mislabeled; summed or non-gated data not saved

VOLUME OF PRODUCT IN COMMERCE 2520 units

DISTRIBUTION Nationwide

 

WEEK ENDING JANUARY 26

 

PRODUCT 1) a non-prescription gauze, labeled in part: "NU GAUZE General-Use Sponges 2 in. x 2 in. - 4ply 2 SPONGES STERILE REORDER 2338 Johnson & Johnson Medical  Division of Ethicon, Inc. Arlington, TX".

2) a non-prescription gauze, labeled in part:  "MIRASORB Sponges 2 in. x  2 in. - 4ply 2 SPONGES STERILE REORDER 602318 Johnson & Johnson Medical Division of Ethicon, Inc. Arlington, TX".Both products are packaged 1500 to a case,

CODE 1) Nu Gauze: Product code 2338 (on front panel of label) and lots:  2001 10 1, 2001 10 2, 2001 10 3, 2001 10 A, 2001 10 B, 2001 10 C, 2001 10 D (on back of package).

2) Mirasorb: Product code 602318 (on front panel of label) and lots: 2001 10 1, 2001 10 2, 2001 10 3 (on back of package).

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 438,000.

DISTRIBUTION Nationwide.

 

PRODUCT Hill-Rom Advanta 1600 series retractable med-surg beds with the optional accessory outlet

CODES All units shipped between April 2000 and March 2001, Serial # A334AB0065, B087AB1863, B087AB1865, B094AB1951, B094AB1952, B094AB1953, B094AB1954, B094AB1955, B094AB1956, B094AB1957, B094AB1958, B094AB1959, B094AB1960, B094AB1962, B094AB1963, B095AB1974, B095AB1975, B095AB1976, B095AB1977, B095AB1978, B095AB1982, B095AB1983, B095AB1984, B095AB1985, B095AB1986, B095AB1987, B095AB1988, B095AB1989, B096AB1996, B096AB1997, B096AB1998, B096AB1999, B096AB2000, B096AB2001, B096AB2003, B096AB2006, B096AB2007, B096AB2008, B097AB2026, B097AB2027, B097AB2032, B098AB2033, B098AB2034, B098AB2035, B098AB2039, B098AB2040, B098AB2041, B098AB2042, B098AB2043, B098AB2044, B098AB2045, B098AB2050, B098AB2051, B098AB2052, B098AB2053, B104AB2124, B104AB2125, B104AB2126, B104AB2127, B104AB2128, B104AB2129, B104AB2130, B104AB2131, B104AB2132, B104AB2133, B104AB2134, B104AB2135, B104AB2136, B104AB2137, B137AB2981, B140AB3051, B140AB3054, B143AB3096, B143AB3097, B143AB3101, B143AB3103, B143AB3106, B143AB3108, B143AB3113, B143AB3115, B143AB3116, B144AB3147, B144AB3148, B144AB3150, B144AB3152, B144AB3153, B144AB3157, B144AB3158, B144AB3161, B144AB3163, B145AB3195, B145AB3196, B145AB3197, B146AB3243, B146AB3246, B146AB3248, B146AB3256, B146AB3257, B146AB3263, B146AB3267, B146AB3271, B157AB3567, B157AB3571, B161AB3757, B172AB4086, B173AB4110, B173AB4114, B173AB4115, B173AB4116, B173AB4117, B173AB4120, B173AB4121, B173AB4122, B174AB4151, B174AB4152, B174AB4153, B174AB4154, B174AB4155, B174AB4156, B174AB4157, B174AB4158, B174AB4159, B174AB4160, B174AB4161, B175AB4192, B178AB4200, B178AB4203, B178AB4206, B178AB4207, B178AB4208, B178AB4212, B178AB4213, B178AB4214, B179AB4235, B179AB4236, B179AB4239, B179AB4241, B179AB4244, B179AB4245, B182AB4330, B182AB4333, B207AB4744, B207AB4751, B207AB4753, B207AB4758, B207AB4759, B208AB4764, B208AB4767, B208AB4770, B208AB4773, B208AB4777, B208AB4781, B208AB4789, B208AB4790, B208AB4794, B208AB4800, B208AB4801, B208AB4803, B208AB4806, B208AB4809, B208AB4811, B209AB4814, B209AB4816, B209AM5058, B209AM5059, B216AB5070, B216AB5073, B216AB5075, B216AB5077, B216AB5080, B216AB5081, B216AB5083, B216AB5084, B216AB5087, B216AB5088, B216AB5092, B216AB5093, B217AB5121, B217AB5123, B217AB5125, B217AB5126, B217AB5128, B217AB5131, B217AB5132, B217AB5133, B217AB5135, B222AB5268, B222AB5271, B222AB5274, B222AB5282, B222AB5283, B222AB5286, B222AB5291, B222AB5292, B222AB5294, B223AB5326, B223AB5328, B223AB5329, B223AB5334, B223AB5338, B223AB5343, B223AB5345, B223AB5347, B223AB5349, B224AB5375, B224AB5376, B224AB5379, B224AB5382, B231AB5672, B231AB5681, B232AB5738, B232AB5746, B232AB5752, B232AB5753, B232AB5755, B232AB5758, B232AB5761, B232AB5765, B232AB5768, B232AB5787, B234AB5805, B234AB5806, B234AB5814, B235AB5858, B235AB5859, B235AB5869, B235AB5870, B235AB5872, B235AB5873, B235AB5874, B235AB5883, B235AB5887, B235AB5890, B235AB5895, B236AB5899, B236AB5901, B236AB5903, B236AB5904, B236AB5922, B236AB5923, B236AB5928, B236AB5929, B236AB5930, B236AB5933, B236AB5939, B236AB5941, B236AB5947, B237AB5959, B237AB5961, B237AB5964, B237AB5966, B237AB5975, B237AB5977, B237AB5978, B237AB5980, B237AB5990, B237AB6001, B237AB6004, B238AB6005, B238AB6006, B238AB6009, B238AB6010, B238AB6011, B239AB6045, B253AB6636, B253AB6637, B253AB6638, B253AB6639, B253AB6640, B253AB6641, B253AB6642, B253AB6643, B253AB6644, B253AB6645, B253AB6646, B253AB6647, B253AB6648, B255AB6649, B255AB6650, B255AB6651, B255AB6652, B255AB6653, B255AB6654, B255AB6655, B255AB6656, B255AB6657, B255AB6658, B255AB6659, B255AB6660, B255AB6661, B255AB6662, B255AB6664, B255AB6666, B255AB6699, B255AB6700, B255AB6701, B255AB6702, B255AB6703, B255AB6704, B255AB6705, B255AB6706, B255AB6707, B255AB6708, B256AB6709, B256AB6710, B256AB6711, B256AB6712, B256AB6713, B256AB6714, B256AB6715, B256AB6716, B256AB6717, B256AB6718, B256AB6719, B256AB6720, B256AB6721, B256AB6722, B256AB6723, B256AB6724, B256AB6725, B256AB6726, B256AB6727, B256AB6728, B256AB6729, B256AB6730, B256AB6734, B256AB6735, B256AB6736, B256AB6737, B256AB6738, B256AB6739, B256AB6740, B256AB6741, B256AB6742, B256AB6743, B256AB6744, B256AB6745, B256AB6746, B256AB6748, B256AB6750, B264AB7297, B264AB7299, B264AB7314, B264AB7321, B264AB7324, B264AB7325, B264AB7328, B264AB7340, B264AB7351, B264AB7354, B265AB7388, B265AB7392, B265AB7402, B272AB7797, B272AB7805, B272AB7806, B272AB7807, B272AB7809, B272AB7812, B272AB7821, B272AB7823, B272AB7824, B272AB7825, B273AB7830,  B273AB7842, B273AB7849, B273AB7851, B273AB7853, B273AB7854, B273AB7859, B273AB7860, B273AB7861, B273AB7864, B273AB7865, B273AB7866, B273AB7870, B273AB7875, B273AB7879, B276AB7899, B276AB7901, B276AB7909, B276AB7912, B276AB7916, B276AB7917, B276AB7921, B276AB7923, B276AB7925, B276AB7930, B276AB7931, B276AB7934, B276AB7942, B276AB7943, B276AB7945, B283AB8324, B283AB8328, B283AB8333, B283AB8334, B283AB8342, B283AB8344, B283AB8346, B283AB8348, B284AB8355, B284AB8360, B284AB8371, B284AB8372, B284AB8373, B284AB8374, B284AB8384, B284AB8386, B284AB8387, B284AB8391, B284AB8400, B284AB8402, B284AB8404, B284AB8407, B284AB8407, B284AB8410, B284AB8411, B284AB8416, B284AB8417, B284AB8418, B284AB8423, B284AB8424, B284AB8429, B284AB8436, B284AB8446, B285AB8453, B285AB8461, B285AB8468, B285AB8470, B285AB8471, B285AB8475, B285AB8479, B285AB8484, B285AB8488, B285AB8490, B285AB8495, B285AB8498, B285AB8506, B285AB8510, B285AB8511, B285AB8512, B285AB8513, B285AB8516, B285AB8523, B285AB8524, B285AB8528, B285AB8531, B285AB8533, B285AB8535, B285AB8536, B286AB8537, B286AB8539, B286AB8541, B286AB8545, B286AB8549, B286AB8550, B286AB8552, B286AB8553, B286AB8556, B286AB8557, B286AB8565, B286AB8566, B286AB8568, B286AB8570, B286AB8571, B286AB8572, B286AB8573, B286AB8581, B286AB8587, B286AB8588, B286AB8589, B286AB8592, B286AB8594, B286AB8596, B286AB8602, B286AB8605, B286AB8608, B286AB8616, B286AB8620, B286AB8621, B286AB8622, B286AB8623, B286AB8627, B286AB8628, B287AB8634, B287AB8637, B287AB8639, B287AB8643, B287AB8646, B287AB8648, B287AB8649, B287AB8653, B287AB8655, B287AB8658, B287AB8661, B287AB8666, B287AB8669, B287AB8670, B287AB8680, B287AB8681, B287AB8683, B287AB8685, B287AB8687, B287AB8688, B287AB8692, B287AB8695, B287AB8696, B287AB8703, B287AB8707, B287AB8710, B287AB8716, B287AB8722, B287AB8723, B287AB8724, B287AB8726, B287AB8730, B287AB8731, B288AB8734, B288AB8738, B288AB8740, B288AB8745, B290AB8747, B290AB8750, B290AB8754, B290AB8757, B290AB8758, B290AB8766, B290AB8767, B294AB9186, B294AB9190, B294AB9192, B294AB9194, B294AB9197, B294AB9198, B294AB9203, B294AB9209, B294AB9211, B298AB9400, B298AB9404, B298AB9408, B299AB9473, B307AB9978, B311AB0232, B312AB0234, B312AB0240, B312AB0242, B312AB0244, B312AB0245, B312AB0254, B312AB0255, B312AB0256, B312AB0261, B312AB0264, B312AB0271, B312AB0274, B312AB0275, B312AB0280, B312AB0281, B312AB0284, B312AB0296, B318AB0663, B322AB0951, B327AB1113, B327AB1115, B327AB1116, B327AB1119, B327AB1121, B327AB1122, B327AB1126, B327AB1127, B327AB1132, B327AB1133, B327AB1135, B327AB1136, B327AB1138, B327AB1140, B327AB1141, B327AB1142, B327AB1145, B327AB1147, B327AB1148, B327AB1150, B336AB1357, B336AB1358, B346AB1898, B346AB1900, B346AB1903, B346AB1907, B346AB1908, B346AB1910, B346AB1913, B346AB1918, B346AB1922, B347AB1929, B347AB1932, B347AB1935, B347AB1937, B347AB1940, B347AB1945, B347AB1946, B347AB1949, B347AB1954, B347AB1958, B347AB1960, B347AB1963, B347AB1964, B347AB1966, B347AB1972, B347AB1976, B347AB1977, B348AB1978, B348AB1980, B348AB1988, B348AB1989, B348AB1990, B348AB1993, B348AB1995, B348AB2000, B348AB2003, B348AB2004, B348AB2005, B353AB2139, B353AB2145, B353AB2150, B354AB2176, B354AB2180, B354AB2181, B354AB2182, B354AB2183, B354AB2184, B354AB2185, B354AB2186, B354AB2191, B354AB2192, B354AB2197, B354AB2203, B354AB2204, B354AB2215, B354AB2217, B354AB2218, B354AB2222, B354AB2228, B354AB2230, B355AB2232, B355AB2237, B355AB2241, C002AB2405, C002AB2409, C002AB2411, C002AB2416, C002AB2417, C002AB2423, C002AB2427, C003AB2431, C003AB2435, C003AB2439, C003AB2442, C003AB2444, C003AB2448, C003AB2449, C003AB2453, C003AB2455, C003AB2460, C003AB2462, C004AB2465, C004AB2467, C004AB2471, C008AB2565, C008AB2566, C008AB2570, C008AB2575, C008AB2576, C008AB2578, C008AB2584, C008AB2585, C008AB2587, C008AB2590, C008AB2595, C008AB2597, C009AB2601, C009AB2603, C009AB2608, C009AB2612, C009AB2615, C009AB2616, C009AB2618, C009AB2619, C009AB2624, C009AB2626, C009AB2627, C009AB2635, C009AB2637, C009AB2638, C009AB2643, C009AB2644, C009AB2648, C009AB2650, C009AB2652, C009AB2655, C009AB2659, C011AB2671, C011AB2675, C011AB2677, C011AB2679, C011AB2682, C011AB2689, C011AB2690, C011AB2691, C011AB2692, C011AB2695, C011AB2700, C011AB2704, C011AB2706, C011AB2707, C011AB2710, C011AB2717, C011AB2719, C016AB2810, C017AB2842, C024AB3045, C024AB3049, C024AB3052, C024AB3055, C024AB3058, C024AB3062, C024AB3063, C024AB3067, C024AB3070, C024AB3073, C025AB3074, C025AB3077, C025AB3080, C025AB3084, C025AB3087, C030AB3212, C036AB3376, C036AB3379, C036AB3384, C036AB3386, C036AB3387, C036AB3389, C037AB3393, C037AB3398, C037AB3399, C037AB3403, C037AB3407, C037AB3408, C037AB3411, C037AB3414, C037AB3419, C037AB3422, C037AB3424, C037AB3427, C037AB3432, C037AB3434, C037AB3447, C037AB3448, C037AB3451, C037AB3453, C037AB3457, C037AB3461, C04B3593, C052AB3877, C052AB3880, C052AB3882, C052AB3886, C052AB3887, C052AB3890, C052AB3893, C052AB3894, C052AB3895, C053AB3899, C053AB3902, C053AB3903, C053AB3906, C053AB3907, C053AB3909, C053AB3912, C053AB3915, C053AB3916, C053AB3918, C053AB3920, C053AB3923, C053AB3924, C053AB3926, C053AB3927, C053AB3930, C053AB3932, C053AB3934, C053AB3937, C053AB3938, C053AB3940, C053AB3942, C053AB3943, C053AB3944, C053AB3945, C053AB3946, C053AB3947, C053AB3948, C053AB3949, C053AB3950, C053AB3951, C053AB3952, C053AB3953, C053AB3954, C053AB3955, C053AB3958, C057AB4004, C057AB4007, C057AB4014, C057AB4020, C057AB4026, C057AB4032, C057AB4034, C058AB4055, C058AB4061, C058AB4067, C058AB4073, C058AB4079, C058AB4085, C058AB4094, C059AB4112, C059AB4119, C059AB4125, C059AB4131, C059AB4137, C059AB4144, C059AB4148, C060AB4157, C060AB4167, C060AB4168, C060AB4179, C060AB4184, C060AB4190, C060AB4196, C060AB4206, C060AB4210, C060AB4215, C061AB4223, C061AB4228, C061AB4238, C061AB4262, C066AB4395, C066AB4398, C066AB4399, C066AB4403, C066AB4405, C066AB4410, C066AB4411, C067AB4442, C067AB4443, C067AB4449, C067AB4451, C067AB4454, C067AB4459, C067AB4462, C067AB4464, C067AB4466, C067AB4471, C068AB4500, C068AB4505, C068AB4509, C068AB4511, C068AB4514, C068AB4521, C068AB4530, C071AB4551, C073AB4702, C073AB4703, C073AB4707, C073AB4710, C074AB4724, C074AB4729, C074AB4731, C074AB4734, C074AB4737, C074AB4740, C074AB4744, C074AB4747, C074AB4752, C078AB4852, C087AB5253, C092AB5412, C094AB5506.

RECALLING FIRM/MANUFACTURER Hill-Rom Company, Batesville, IN

REASON Optional accessory outlet cable not secured properly and may be damaged with use and cause fire.

VOLUME OF PRODUCT IN COMMERCE 932 units.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console

CODE Serial Numbers: 3019 through 3050, 3052, 3053, 3055 and 3056.

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

REASON Console's audible alarm may fail to signal.

VOLUME OF PRODUCT IN COMMERCE 36.

DISTRIBUTION Nationwide.

 

PRODUCT Cordis Nylex 5F Flush Angiographic Catheters (Product Number 526510) and Cordis Tempo 4F Selective Diagnostic Catheters (Product Numbers 4514**VO)

CODE Product Number 526510, Lot Number R0401411

               451442VO Lot Number 50401670

               451443VO Lot Number W0401196

               451413V0 Lot Number W0401377

RECALLING FIRM/MANUFACTURER Recalling Firm: Cordis Corp. Miami Lakes, FL

Manufacturer: Cordis Europa Roden, Netherlands.

REASON Increased tip stiffness with a potential for vessel damage.

VOLUME OF PRODUCT IN COMMERCE 135.

DISTRIBUTION Nationwide

 

PRODUCT 6.5EC10 Disposable Biopsy Guide, P/N 5269613

CODE Mfg date 2000.07.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Siemens Medical Solutions USA, Inc Issaquah, WA

Manufacturer:  Civco Kalona, IA

REASON Disposable biopsy guide does not fit properly on the transducer and may shift.

VOLUME OF PRODUCT IN COMMERCE 251 boxes each containing 20 disposable biopsy guides.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Hemoliance Brain Thromboplastin (HBT), 12 mL: Prothrombin Time Test. 

CODE Part No. 49732400 Lot No.: N0415055 Exp. Date: 08/04.

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

Manufacturer: Instrumentation Laboratory Co. Orangeburg, NY.

REASON International Sensitivity Index (ISI) incorrectly assigned for Prothrombin Time.

VOLUME OF PRODUCT IN COMMERCE 559 kits.

DISTRIBUTION FL.

 

PRODUCT

Marisa Patient Lift, Non-AC Powered; Arjo Inc., Roselle, IL 60172

Model KGB2000-US, Marisa Complete with Jib and no Scale

Model KGB2100-US, Marisa Complete with Jib and Scale,

CODE Models KGB2000-US and KGB2100-US, serial numbers GB 4697 792463 001 to GB 1099 819522 010.

RECALLING FIRM/MANUFACTURER Recalling Firm: Arjo, Inc., Roselle, IL

Manufacturer: Arjo Limited Gloucester, United Kingdom.

REASON Improper alignment of jib assembly to lift carriage.

VOLUME OF PRODUCT IN COMMERCE 1,431 units.

DISTRIBUTION AZ, WI and VA.

 

PRODUCT Marquest Ventilator Circuit w/Volume Vent Manifold.

CODE

Product Code Lot#

1561133      #493N

1570035      #838L

156355       #260N, 156P, 338M, 339M, 354N, 368M, 419N, 461M, 419N, 525M, 461M, 625N, 638M, 787M, 880L, 952N

1570240      #721M, 776N

1571134      #430N, 526M, 600M, 665N, 990L,

1572099      #175M, 291M, 643M, 312N, 821N, 854M,

1572336      #494N

1576689      #865M

157355       #152M, 190P, 313M, 575N, 722M, 860M

1576712      #215N, 231P, 282M, 372N, 445M, 525N, 564M, 784M, 889L, 800L, 990N

157516       #827N

1576006      #276N, 283M, 497M, 433N, 567M, 630M, 691M

1576380      #102N

4P78ENSP     #950N

4S78EXSP     #292M, 668N

6463         #195M, 351N, 706N, 361L, 707N, 456M, 826N, 572M, 870K, 704N, 965L, 705N,

6464         #112N, 154M, 196M, 313N, 683N, 349M, 953M, 363L, 966L, 365M, 968M, 457M, 573N.

RECALLING FIRM/MANUFACTURER Marquest Medical Products, Inc. Englewood, CO

REASON Cracked Exhalation Valve Caps on ventilator circuits.

VOLUME OF PRODUCT IN COMMERCE 32130 units.

DISTRIBUTION Nationwide and Argentina, Canada, Japan, Saudi Arabia and Singapore.

 

PRODUCT Atrium water seal chest drain, Ocean 2002 with preconnected ATS blood bag

CODE Model 2250 Order Number: 2002-057 Lot Numbers: P990049, P990086, P990083, 002042-057, 002160-057, 002175-057.

RECALLING FIRM/MANUFACTURER Atrium Medical Corp. Hudson, NH

REASON Seal integrity of Blood Bag compromised resulting in blood leakage.

VOLUME OF PRODUCT IN COMMERCE 498 units.

DISTRIBUTION IA and VA.

 

PRODUCT Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System

CODE Version 2.2a Catalog # PL01.

RECALLING FIRM/MANUFACTURER Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA

Manufacturer: BioChem ImmunoSystems Italia Spa Guidonia Montecello, Rome.

REASON Samples were not picked up and added to the dilution tube.

VOLUME OF PRODUCT IN COMMERCE 17 units.

DISTRIBUTION Nationwide.

 

PRODUCT VISION T-22 Gamma Camera System

CODE Serial Numbers 1 thru 50.

RECALLING FIRM/MANUFACTURER Recalling Firm: G. E. Medical Systems Twinsburg, OH

Manufacturer: Hitachi Medical Corp. Chiyoda-Ku, Tokyo, Japan.

REASON The collimator bolts may fail and allow the collimator to drop. Injury may result.

VOLUME OF PRODUCT IN COMMERCE 47.

DISTRIBUTION Nationwide.

 

PRODUCT Resuscitaion bag component in an assembled custom surgical kit, Non sterile, lableled in part: "open heart sgl pull items jewish hosp Healthcare, lot #, expiration, reorder # ht0586. Note that only the Resuscitaion bag component was under recall and not the entire kit. 

CODE Catalog No. HT0586, Lot Nos.(Work Nos.)13216, 14019, 14201, 14418, 15195, 15312, 16142, 16416, 16872.

RECALLING FIRM/MANUFACTURER Recalling Firm: SRI/Surgical Express Tampa, FL

Manufacturer: Alliance Healthcare McGaw Park, FL.

REASON Component Resuscitation Bag recalled due to improper duck bill action.

VOLUME OF PRODUCT IN COMMERCE 1460 packs.

DISTRIBUTION KY.

 

PRODUCT a) Medtronic Bio-Medicus Femoral Cannula and Introducer; 17 Fr.. 

b) Medtronic Bio-Medicus Femoral Cannula and Introducer; 19 Fr.

CODE a) Product code 96570-017.  Lot 2001070003. b) Product code 96570-019.  Lot 2001070038.

RECALLING FIRM/MANUFACTURER Medtronic Cardiac Surgical Products Grand Rapids, MI

REASON Cannula size not as labeled.

VOLUME OF PRODUCT IN COMMERCE 15.

DISTRIBUTION CA, CT, FL, IL, NC, OH, WA and Canada.

 

PRODUCT 3M Tegagel Hydrogel Wound Filler, 3 oz. tube, Catalog Number 90412, 

CODE Lot 6104101, Expiration date 05/03.

RECALLING FIRM/MANUFACTURER Recalling Firm: 3M Health Care, 3M Company St. Paul, MN

Manufacturer: Darja Laboratories, Inc. Minden, NV.

REASON The product tubes were filled with a different brand of a similar product which has many of the same ingredients.

VOLUME OF PRODUCT IN COMMERCE 5508 tubes.

DISTRIBUTION Nationwide, Canada and Korea. 

 

PRODUCT Pathromtin Reagent

CODE Catalog # OTXA25 Lot numbers 543803 exp. 2/1/02, 543804 exp. 7/26/02, and 543805 exp 1/28/02.

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

Manufacturer: Dade Behring Marburg GMBH Marburg.

REASON Prolonged APTT clotting times.

VOLUME OF PRODUCT IN COMMERCE 3502 units.

DISTRIBUTION Nationwide

 

PRODUCT Immulite Tree Specific IgE; 100 test Kit Id# LKTR1 116 Not cleared for domestic distribution

CODE All Codes.

RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA

REASON Packaging equipment failure causing missing bead component.

VOLUME OF PRODUCT IN COMMERCE  8.

DISTRIBUTION International

 

PRODUCT Immulite Total IgE; Radioimmunoassay; Packed in 100 test kit under ID#: LKIE 1 160 and in 500 test kit under ID# LKIE 5 160

CODE All lots.

RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA

REASON Packaging equipment failure.

VOLUME OF PRODUCT IN COMMERCE 612 of both sizes 100/500.

DISTRIBUTION International.

 

PRODUCT Ortho Development Cancellous Bone Screw Dia. 6.5mm x 35mm. Catalog No. 146-1035, Lot No. W011026

CODE Catalog Number: 146-1035, Lot No. W011026

RECALLING FIRM/MANUFACTURER Ortho Development Corp., Draper, UT

REASON 40mm Cancellous Bone Screws were labeled as 35mm.

VOLUME OF PRODUCT IN COMMERCE 6 screws.

DISTRIBUTION UT and Japan.

 

PRODUCT Bion Epstein-Barr (VCA) Antigen Substrate For IFA Test System, 12 Well Slide; Bion Enterprises, Ltd., Park Ridge, IL.  The 12 Well Slides are packaged individually as product number EB-5012, and as a component of the EBV-M (VCA) Test System, product number EMB-120, with 10 slides per kit

CODE Product No. EB-5012, lot EB-0843. The slides were also packed into Product No. EBM-120, lot KEBMT-039.

RECALLING FIRM/MANUFACTURER Bion Enterprises, Ltd. Des Plaines, IL

REASON The slides were difficult to read using IgM testing.

VOLUME OF PRODUCT IN COMMERCE 545 slides.

DISTRIBUTION IA, SC, MN, WV, TX, IL and England.

 

PRODUCT Calibration Solution: IL Test Cal 1 Solution (500 mL) for IL Synthesis Analyzers Models 1720 and higher

CODE Part Number: 98332-00 Lot Number: N0518679 Exp.Date: 5/02.

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

Manufacturer: Instrumentation Laboratories Orangeburg, NY.

REASON Calibrator may cause abnormally low or high calcium and chloride QC values.

VOLUME OF PRODUCT IN COMMERCE 1521 bottles.

DISTRIBUTION Nationwide and Mexico; Intermedico Canada.

 

PRODUCT MediSense Optium Blood Glucose Test Strips for use with the MediSense Optium Blood Glucose Monitoring System

[50 test strips/box]. 

CODE Part Number: 99134-15 Lot Numbers: 50111, 50113, and 50123Expiration Date: 30 SEP 2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Medisense Products Bedford, MA

Manufacturer: Medisense United Kingdom Limited Abingdon, United Kingdom. 

REASON Incorrectly programmed calibrator fails to calibrate the glucose meter.

VOLUME OF PRODUCT IN COMMERCE 3570 boxes of 50.

DISTRIBUTION FL and OH.

 

PRODUCT Vaxcel Implantable Access Port Mini Port, Titanium 6 F, Polyurethane Catheter.

CODE Catalog Number: 45-303 Lot Number: 0699.

RECALLING FIRM/MANUFACTURER Recalling Firm: Meditech a Division of Boston Scientific Corp. Watertown, MA

Manufacturer: Gerard Medical, Inc. Charlton City, MA.

REASON Device Mislabeled as 6 French Instead of an 8 French Dilator

VOLUME OF PRODUCT IN COMMERCE 59.

DISTRIBUTION Nationwide

 

PRODUCT Industrial first aid kits consisting of cabinets filled with medical supplies including Medi First Plus Pain Relieving Burn

Spray with Aloe Vera Antiseptic Anesthetic, lot 0010004, and/or Medi First Plus Pain Relieving Antiseptic Spray, lot 0003092;

CODE

Product code 723REST, lot 5679 and 5945

Product code 745LSC, lot 5681

Product code 756LSC, lot 5680

Product code P786GDX, lot 5802 and 6587

Product code P956DX, lot 4809, 5194, 6152, 6175 and 6185

Product code P964DX, lot 4301, 4425, 5125, 5700 and 6614.

RECALLING FIRM/MANUFACTURER Textilease Medique Wood Dale, IL

REASON First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent.

VOLUME OF PRODUCT IN COMMERCE 2994 kits.

DISTRIBUTION Nationwide.

 

PRODUCT First Aid Kits

CODE There are no codes applied to the various First Aid Kits affected.

RECALLING FIRM/MANUFACTURER Zee Service Inc. Irvine, CA

REASON First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent.  Also, leaking containers or loose caps.

VOLUME OF PRODUCT IN COMMERCE  Not disclosed. 62 domestic customers.

DISTRIBUTION  Nationwide and to Canada.