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DATE RECALL INITIATED:
PRODUCT:
Catalog Numbers:
777800-400 Trima Accel LRS Platelet, Plasma, RBC Set
777800-450 Trima Accel LRS Platelet, Plasma, RBC and TLR Filter Set
LOT NUMBER / EXPIRATION DATE :
05KXXXX 5/2006
06KXXXX 6/2006
MANUFACTURER:
Gambro BCT, Inc.
Lakewood, Colorado
REASON:
Gambro BCT recently began to receive an increased number of reports of significantly lower yields/concentrations on platelet products that were collected on the Trima Accel Automated Blood Collection System. The problem is related to a weak connector weld within the separation channel of the tubing set. Not all tubing sets are affected. For tubing sets affected by this problem, the resulting platelet product has an acceptable volume, but a significantly lower platelet yield/concentration (typically less than 70% of predicted). Consignees have been asked to either use lot numbers 07K and above, and return any 05K and 06K product remaining in inventory OR perform pre-release platelet counts on the final product collected using a 05K or 06K lot.
Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System - 7/23/2004
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.
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