Cobe Cardiovascular, Inc ASY, Brat Pack Procedure Set Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ASY, Brat Pack Procedure Set
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
Catalog Number: 007214102. Lot numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005, 0514400007, 0514400008, 0515100189
Products Sold
Catalog Number: 007214102. Lot numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005, 0514400007, 0514400008, 0515100189
Cobe Cardiovascular, Inc is recalling ASY, Brat Pack Procedure Set 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