BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green),
FDA device recall Z-0468-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- The catheter connector could not be sufficiently tightened to secure the catheter tubing.
- Action taken
- Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCD
- Quantity affected
- 1410 units
- Distribution
- The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
- Date initiated
- 2005-11-17
- Date posted
- 2006-02-04
- Date terminated
- 2008-03-03
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER (K850505) | Parke-Davis Co. | 1985-03-11 |