FDA Device recall Z-2514-2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes by Kentec Medical, citing feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2514-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-17 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Kentec Medical |
| Distribution | CA, IA, VA |
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
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.
Identifiers
| code_info | Lot Number: KS1711017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2514-2020%22
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