Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
This recall has been terminated (originally issued September 9, 2006).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- August 4, 2006
- Posted
- September 9, 2006
- Terminated
- December 28, 2011
- Recall Number
- Z-1491-06
- Quantity
- 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Distribution
Nationwide, including VA facilities in CA and OH
Lot / Code Info
COBE Product Code-ASCBFE22, Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109, 0621300094-- COBE Product Code-ASCBE22, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128, 0619200116, 0619900053, 0621300093--COBE Product Code- AS9E55, Lot Numbers: 0617200004, 0619900054, 0621300095-COBE Product Code- AS9E22, Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092--COBE Product Code- AS9E12, Lot Numbers: 0612300035, 0615000022, 0616400011, 0618600108, 0619900052-COBE Product Code- AS4E55, Lot Numbers: 0616400012, 0618600110- COBE Product Code-AS4E22, Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051-COBE Product Code- AS4E17, Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055.
Root Cause
Other
Action Taken
Consignees were notified by telephone and e-mail on 08/04/2006.