Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile Recalled by Kentec Medical, Inc Due to Feeding tube plastic tethered closure cap may possibly...

Date: January 17, 2020
Company: Kentec Medical, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kentec Medical, Inc directly.

Affected Products

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).

Quantity: 2130

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: CA, IA, VA

Affected (3 states)Not affected

About Kentec Medical, Inc

Kentec Medical, Inc has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report