Z-2516-2020Class II

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog...

Name: Z-2516-2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog...
Creator: Kentec Medical, Inc
Published: 2020-01-17
License: https://open.fda.gov/license/

Kentec Medical, LLC / initiated 2020-01-17 / Terminated

FDA source

Kentec Medical, Inc began a recall of Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral... on 2020-01-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2516-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-17
Posted: 2020-07-08
Terminated: 2022-10-21
Recalling firm: Kentec Medical, LLC
Product: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
Product code: FPD Tube, Feeding
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.
FDA root cause: Under Investigation by firm
Action: On 01/02/2020, the firm notified affected customers via mail of "'URGENT' VOLUNTARY RECALL NOTICE". The letter indicated to IMMEDIATELY stop use of affected product and to move affected product to a location that prevents potential use. Contact the firm immediately, via the phone number (800-825-5996) or email to arrange return of the affected product. Complete and sign the attached Voluntary Recall Response Form, to acknowledge the receipt and understanding of the content incorporated. Return completed form within five (5) business days to the firm.
Quantity in commerce: 710
Distribution: US: CA, IA, and VA
Product codes and lots: Lot Number: KS1706021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2516-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2514-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2515-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2516-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2517-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2518-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2519-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06
Z-2520-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06

Product code FPD

K100526Class IIAmeritus Entral (Tm) Enteral Feeding TubeKentec Medical, Inc. / cleared 2010-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)