Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
This recall has been terminated (originally issued July 20, 2004).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- May 25, 2004
- Posted
- July 20, 2004
- Terminated
- March 31, 2005
- Recall Number
- Z-1009-04
- Quantity
- 216 sets
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
Lot / Code Info
Catalog # 027770201, Lot # 0406800015.
Root Cause
Other
Action Taken
Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
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