Kentec Medical Inc: Medical Device Recall in 2017 - (Recall #: Z-3073-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 23, 2017

Date Posted: September 6, 2017

Recall Number: Z-3073-2017

Event ID: 77729

Reason for Recall:

Inadequate detectability of radiopaque stripes

Status: Terminated

Product Quantity: 54 boxes of 10 individual units

Code Information:

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

Distribution Pattern:

TX, VA, IL, CA, KS

Voluntary or Mandated:

Voluntary: Firm initiated