Recall
Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems
DATE RECALL INITIATED:
November 26, 2007
PRODUCT / LOT NUMBERS:
COBE Spectra Disposable Tubing Sets
Catalog Number Tubing Set Name Lot Number 000777110 Dual-Needle Extended Life Platelet Set with LRS Chamber 03N0005
04NXXXXX
05NXXXXX
06NXXXXX
07N1524770100 Dual-Needle Extended Life Platelet Set 04NXXXXX
05NXXXXX
07N1524470300 Dual-Needle Extended Life Platelet Set with LRS Chamber 03N0006
04NXXXXX
05NXXXXX
06NXXXXX
07N1524670310 Dual-Needle Extended Life Platelet Set with LRS Chamber 04NXXXXX
05NXXXXX
06NXXXXX70400 Single-Needle Extended Life Platelet Set with LRS Chamber 04NXXXXX
05NXXXXX
07N15228777003005 Dual- Needle Extended Life Platelet Set 04NXXXXX
05NXXXXX777003015 Dual-Needle Extended Life Platelet Set with LRS Chamber 03N15290
04NXXXXX
05NXXXXX
06NXXXXX
07N15245
07N15306777003215 Single-Needle Extended Life Platelet Set with LRS Chamber 03N15288
03N15289
04NXXXXX
05NXXXXX
06NXXXXX
07N15216
Trima Automated Blood Collection Disposable Tubing Sets
Catalog Number Tubing Set Name Lot Number 777800100 Trima LRS Platelet, Plasma, RBC Set with Sharps Protection 03N1130
04NXXXX
05NXXXX
06NXXXX
07N1105777800400 Trima Accel LRS Platelet, Plasma, RBC Set 03N1116
03N1121
03N1126
03N2116
03N3116
03N3120
03N3126
03N3230
04NXXXX
05NXXXX
06NXXXX
07N1118
07N2105
07N2113
07N2116
07N2203
07N2224
07N3102
07N3112
07N3117
07N3119
07N3124
07N3126
07N3131
07N3226
07N3230777800401 Trima Accel LRS Platelet, Plasma, RBC Set 04NXXXX
05NXXXX
06NXXXX
07N9101
07N9102
08N9101777800403 Trima Accel LRS Platelet, Plasma, RBC Set 03N3128
04NXXXX
05NXXXX
06NXXXX
07N3116777800450 Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set 04NXXXX
05NXXXX
06NXXXX
07N3105777800451 Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set 07N9104 777800453 Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set 03N3130
04NXXXX
05NXXXX
07N321380300 Trima Accel LRS Platelet, Plasma Set 03N0002
03N1003
03N1004
03N2123
04NXXXX
05NXXXX
06NXXXX
07N2110
07N2112
07N212480400 Trima Accel LRS Platelet, Plasma, RBC Set 03N2129
03N3124
04NXXXX
05NXXXX
06NXXXX
07N3111
07N3118
07N312380410 Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set 05NXXXX
06NXXXX80411 Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set 06NXXXX 80413 Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set 05NXXXX
06NXXXX80420 Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set 05NXXXX 80440 Trima Accel Enhanced Platelet, Plasma, RBC Set 04NXXXX
06NXXXX
07N2219
07N3109
07N320580449 Trima Accel Enhanced Platelet, Plasma, RBC Set 03N2119
03N2121
03N2122
03N2127
03N2128
03N2226
04NXXXX
05NXXXX
06NXXXX
07N1111
07N1116
07N1123
07N212680450 Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set 03N3121
05NXXXX
07N331380460 Trima Accel PPC, Plasma, RBC + TLR Filter Set 04NXXXX
06NXXXX80480 Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set 05NXXXX 80483 Trima Accel LRS Platelet, Plasma, RBC + TLR Filter+ Auto P.A.S. Set 05NXXXX 80490 Trima Accel Enhanced PPC, Plasma, RBC Set 03N3123
04NXXXX
06NXXXX
07N311380491 Trima Accel Enhanced PPC, Plasma, RBC Set 03N9102
04NXXXX
06NXXXX
07N9103
MANUFACTURER:
Gambro BCT, Inc.
Lakewood, CO
REASON:
Gambro BCT is receiving a number of reports of a leak occurring near the spike port on the secondary platelet collect bag on COBE Spectra and Trima tubing sets. The secondary platelet bag does not have the Platelet Product Sampler (sample bulb). The leak is very small and occurs consistently in the same location. These leaks are observed during run as well as post collection. Not all individual sets within the affected lots contain the defect. Only those tubing sets assembled with a secondary platelet bag containing the numeric identifiers 12, 4 have potential for the defect. The identifier can be found near the spike port of the bag. Because of the infrequent occurrence of this defect and the low safety risk, you may continue to use COBE Spectra and Trima sets within the affected lots as long as you do not use kits which contain secondary platelet collect bags with the 12, 4 numeric identifiers. Prior to loading the set, identify the potentially affected secondary platelet collect bag. If any individual sets contain a suspect bag, do not use these sets. Customers are asked to contact the manufacturer to arrange for return of kits with the the suspect platelet collect bag.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.