Class II — Epimed International, Inc.
| 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 | Terminated |
| Reason | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off |
| Product | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less |
| Quantity | 5835 units |
| Distribution | US Nationwide distribution |
| Initiated | 2021-02-01 |
| Classified | 2021-03-18 |
| Terminated | 2022-10-17 |
| Recall number | Z-1276-2021 |
| 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, Inc. (Z-1276-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87333/
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