Custom heart lung perfusion packs
FDA device recall Z-0265-06 · posted 2005-12-02 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- Reason for recall
- One way valve in the heart lung pack assembly may be missing.
- Action taken
- Consignees notified by letter on 10/06/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTM
- Quantity affected
- 21,512 units
- Distribution
- Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
- Date initiated
- 2005-10-06
- Date posted
- 2005-12-02
- Date terminated
- 2011-08-05
- Location
- Arvada, CO
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