ASY, Brat Pack Procedure Set
This recall has been terminated (originally issued August 3, 2005).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- June 22, 2005
- Posted
- August 3, 2005
- Terminated
- July 27, 2006
- Recall Number
- Z-1072-05
- Quantity
- 2912 units
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
Distribution
Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
Lot / Code Info
Catalog Number: 007214102. Lot numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005, 0514400007, 0514400008, 0515100189
Root Cause
Other
Action Taken
Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005
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