Cobe Cardiovascular, Inc Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Cobe Cardiovascular, Inc is recalling Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22 due to Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Recommended Action
Per FDA guidance
Consignees were notified by telephone and e-mail on 08/04/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026