Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
FDA device recall Z-0960-03 · posted 2003-07-02 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- Reason for recall
- Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
- Action taken
- All consignees were contacted by telephone on 05/09/2003, followed by a letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTN
- Quantity affected
- 60 units
- Distribution
- MN, NE, OK
- Date initiated
- 2003-05-09
- Date posted
- 2003-07-02
- Date terminated
- 2003-07-08
- 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 |