Class II — Kentec Medical, Inc
| Recalling firm | KENTEC MEDICAL, INC. |
|---|---|
| Registered facility | KENTEC MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method. |
| Product | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube). |
| Quantity | 710 |
| Distribution | US: CA, IA, and VA |
| Initiated | 2020-01-17 |
| Classified | 2020-07-06 |
| Terminated | 2022-10-21 |
| Recall number | Z-2516-2020 |
| 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 — Kentec Medical, Inc (Z-2516-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85430/
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