# FDA recall Z-3073-2017

> **Kentec Medical Inc** · Class II · device recall initiated 2017-06-23.

## Product

POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers:    a) ENF-50P-40  b) ENF-50P-50  c) ENF-50P-80  d) ENF-60P-40  e) ENF-60P-50  f) ENF-60P-80  g) ENF-80P-40  h) ENF-80P-50  i) ENF-80P-80  j) ENF-100P-110  For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

## Reason for recall

Inadequate detectability of radiopaque stripes

## Distribution

TX, VA, IL, CA, KS

## Key facts

- **Recall number:** Z-3073-2017
- **Recalling firm:** Kentec Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-23
- **Report date:** 2017-09-06
- **Termination date:** 2020-04-14

- **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-3073-2017

## Citation

> AI Analytics. FDA recall Z-3073-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3073-2017. Source: US FDA. Licensed CC0.

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