Z-3073-2017Class II

POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d)...

Name: Z-3073-2017 POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d)...
Creator: Kentec Medical Inc
Published: 2017-06-23
License: https://open.fda.gov/license/

Kentec Medical, LLC / initiated 2017-06-23 / Terminated / root cause: manufacturing process

FDA source

Kentec Medical Inc began a recall of 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... on 2017-06-23. FDA classified it as Class II and gives the reason as "Inadequate detectability of radiopaque stripes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3073-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Posted: 2017-07-22
Terminated: 2020-04-14
Recalling firm: Kentec Medical, LLC
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.
Product code: FPD Tube, Feeding
Reason for recall: Inadequate detectability of radiopaque stripes
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified their consignees by telephone and email on 06/23/2017, and followed with a letter sent certified mail, on 07/07/2017. The letter instructed the consignee to cease use of the product, isolate it, and contact Kentec.
Quantity in commerce: 54 boxes of 10 individual units
Distribution: TX, VA, IL, CA, KS
Product codes and lots: a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3073-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3073-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25
Z-3074-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

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)