Recall Z-2313-2021 ยท BSO Catheter, Conduction, Anesthetic
Epimed International
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
| Date | Dec 28, 2017 |
| Status | Completed |
| Reason | Potential for stylet to protrude from the distal end of the catheter |
| Root cause | Process control |
| Action | On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers. Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017. The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product. Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible. |
| Quantity | 140 units |
| Distribution | Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981329 | FETH-R-KATH Epimed International, Inc., Aug 26, 1998 |