Class II — Epimed International
| Recalling firm | Epimed International, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Potential for stylet to protrude from the distal end of the catheter |
| Product | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile |
| Quantity | 140 units |
| Distribution | Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran. |
| Initiated | 2017-12-28 |
| Classified | 2021-08-18 |
| Recall number | Z-2313-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Epimed International (Z-2313-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88317/
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