Recall Z-3074-2017— Kentec Medical Inc

Name: FDA recall Z-3074-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-23

Class II · Terminated

Class II FDA medical device recall by Kentec Medical Inc, initiated 2017-06-23, terminated 2020-04-14. It names one FDA 510(k) clearance: K100526. Product: POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.. Reason: Inadequate detectability of radiopaque stripes.

Recalling firm: Kentec Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Terminated: 2020-04-14
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEKentec Medical, Inc.·cleared 2010-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.