Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
FDA device recall Z-1009-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- 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.
- Action taken
- Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTN
- Quantity affected
- 216 sets
- Distribution
- AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
- Date initiated
- 2004-05-25
- Date posted
- 2004-07-20
- Date terminated
- 2005-03-31
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847) | Sorin Biomedical, Inc. | 1994-04-15 |