Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
This recall has been terminated (originally issued July 2, 2003).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- May 9, 2003
- Posted
- July 2, 2003
- Terminated
- July 8, 2003
- Recall Number
- Z-0960-03
- Quantity
- 60 units
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
Distribution
MN, NE, OK
Lot / Code Info
Catalog # 027819201, Lot Number 0304300106.
Root Cause
Other
Action Taken
All consignees were contacted by telephone on 05/09/2003, followed by a letter.
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