Recall Z-0086-2017 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Epimed International, Inc.
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
| Date | Apr 22, 2016 |
| Status | Terminated |
| Reason | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention. |
| Root cause | Employee error |
| Action | On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0 |
| Quantity | 576 units |
| Distribution | US Distribution to the states of : AL, AK, FL, IN, TN & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072005 | RK EPIDURAL NEEDLE Epimed International, Feb 7, 2008 |