Custom heart lung perfusion packs
This recall has been terminated (originally issued December 2, 2005).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- October 6, 2005
- Posted
- December 2, 2005
- Terminated
- August 5, 2011
- Recall Number
- Z-0265-06
- Quantity
- 21,512 units
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
One way valve in the heart lung pack assembly may be missing.
Distribution
Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
Lot / Code Info
210 unique catalog numbers with 779 unique lot numbers.
Root Cause
Other
Action Taken
Consignees notified by letter on 10/06/2005.
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