Recall Z-0468-06 ยท GCD Connector, Catheter
Becton Dickinson & Company
BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and
| Date | Feb 4, 2006 (initiated Nov 17, 2005) |
| Status | Terminated |
| Reason | The catheter connector could not be sufficiently tightened to secure the catheter tubing. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1410 units |
| Distribution | The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850505 | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER Parke-Davis Co., Mar 11, 1985 |