Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. 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-1490-06
- 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-AS4C12, Lot numbers: 0611600045, 0615000020, 0616400010, 0617800124, 0618600111, 0619200113, 0620600004-COBE Product Code- AS4C22, Lot Numbers: 0611600044, 0615000019, 0616400009, 0619200112, 0620600003, 0621300089-COBE Product Code- ASCBC12C, Lot Numbers: 0615700004, 0618600106, 0621300091-COBE Product Code-ASCBC22C, Lot Numbers: 0614300112, 0617100072, 0617800125, 0619200114, 0620600005- COBE Product Code-ASCBFC22C, Lot Numbers: 0611600046, 0613000074, 0613600144, 0615000021, 0615700003, 0617100073, 0617800126, 0619200115, 0619900050, 0620600006.
Root Cause
Other
Action Taken
Consignees were notified by telephone and e-mail on 08/04/2006.