Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Univers
FDA device recall Z-0081-2007 · posted 2006-10-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
- Action taken
- Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFA
- Quantity affected
- 80
- Distribution
- Nationwide.
- Date initiated
- 2006-09-21
- Date posted
- 2006-10-28
- Date terminated
- 2007-05-03
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CATHETERS, BILIARY CATHETERS, UROLOGICAL (K944290) | Boston Scientific Corp | 1994-12-08 |