Cobe Cardiovascular, Inc Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
Brand
Cobe Cardiovascular, Inc
Lot Codes / Batch Numbers
Catalog # 027770201, Lot # 0406800015.
Products Sold
Catalog # 027770201, Lot # 0406800015.
Cobe Cardiovascular, Inc is recalling Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt due to Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
Recommended Action
Per FDA guidance
Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
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 noticeDistribution
As reported by FDA
AL, AZ, FL, KS, MN, MO, NV, TX, WI
Page updated: Jan 10, 2026