Epimed International Recall 88317
Description: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Epimed International Recall 88317 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2313-2021 |
| Event ID | 88317 |
| Event Description | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile |
| Product Type | Devices |
| Distribution | Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran. |
| Quantity | 140 units |
| Recall Reason | Potential for stylet to protrude from the distal end of the catheter |
| Device Classification | 20210825 |
| Device Code Info | Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022) |
| Center Classification Date | 20210818 |
| Recall Initiation Date | 20171228 |
| Recalling Firm | Epimed International |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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