ASY, Brat 2 Procedure Set
FDA device recall Z-1074-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- 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.
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 112 units
- Distribution
- Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
- Date initiated
- 2005-06-22
- Date posted
- 2005-08-03
- Date terminated
- 2006-07-27
- 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 |
|---|---|---|
| BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM (K933625) | Cobe Cardiovascular, Inc. | 1993-12-29 |