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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Trima Accel LRS Tubing Sets-Gambro BCT, Inc

DATE RECALL INITIATED:

August 16, 2004

This is related to Notifications sent by Gambro BCT dated 7/22/2004 and 8/16/2004

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448