Cobe Cardiovascular, Inc ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ASY Brat 2 Procedure Set, for blood recovery & autotransfusion.
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
Catalog Number 007213100, Lot Numbers 0511600003, 0512300003, 0513000003, 0513700003, 0514400005
Products Sold
Catalog Number 007213100, Lot Numbers 0511600003, 0512300003, 0513000003, 0513700003, 0514400005
Cobe Cardiovascular, Inc is recalling ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. due to Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
Recommended Action
Per FDA guidance
Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005
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