CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical

Kentec Medical is recalling Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes, distributed in California, Iowa, Virginia. The recall was initiated on 17 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: KS1810008

Quantity recalled4710

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-2518-2020
FDA event ID: 85430
Recalling firm: Kentec Medical, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Jan 2020
FDA classified: 6 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

17 Jan 2020	Recall initiated by company
6 Jul 2020	Classified by FDA	+171 days
15 Jul 2020	Published in enforcement report	+9 days

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

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).

Where it was distributed

US: CA, IA, and VA

California Iowa Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: KS1810008

Where was it sold?

US: CA, IA, and VA

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

6 other products · FDA event 85430

This product is part of a recall event; the main page for the event is Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA
15 Jul 2020	CLASS II	Ameritus Medical Products ENFit Polyurethane recalled by Kentec Medical	Kentec Medical	Foreign Material	CA, IA, VA

More recalls from Kentec Medical

All 9

Reported	Class	Recall	Company	Reason	Where
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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