CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report

Polyurethane ENFit(R) Ameritus NG Feeding Tube, With Side Port recalled

Kentec Medical is recalling Polyurethane ENFit(R) Ameritus NG Feeding Tube, With Side Port, distributed in California, Illinois, Kansas, Texas, Virginia. The recall was initiated on 23 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038

Quantity recalledK100526

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3074-2017
FDA event ID: 77729
Recalling firm: Kentec Medical, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2017
FDA classified: 25 Aug 2017
Reported: 6 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Jun 2017	Recall initiated by company
25 Aug 2017	Classified by FDA	+63 days
6 Sep 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Inadequate detectability of radiopaque stripes

Product as listed by the FDA

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.

Where it was distributed

TX, VA, IL, CA, KS

California Illinois Kansas Texas Virginia

Questions about this recall

Why was it recalled?

Inadequate detectability of radiopaque stripes

Which lots are affected?

a) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038

Where was it sold?

TX, VA, IL, CA, KS

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 77729

This product is part of a recall event; the main page for the event is Polyurethane ENFit(R) Ameritus NG Feeding Tube recalled.

Reported	Class	Recall	Company	Reason	Where
6 Sep 2017	CLASS II	Polyurethane ENFit(R) Ameritus NG Feeding Tube recalled	Kentec Medical	Other	5 states

More recalls from Kentec Medical

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15 Jul 2020Device	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020Device	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020Device	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020Device	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020Device	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA

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