# FDA recall Z-2520-2020

> **Kentec Medical, Inc** · Class II · device recall initiated 2020-01-17.

## Product

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).

## Reason for recall

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.

## Distribution

US: CA, IA, and VA

## Key facts

- **Recall number:** Z-2520-2020
- **Recalling firm:** Kentec Medical, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-17
- **Report date:** 2020-07-15
- **Termination date:** 2022-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2020

## Citation

> AI Analytics. FDA recall Z-2520-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2520-2020. Source: US FDA. Licensed CC0.

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