Kentec Medical Inc recalls POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y

Recalled September 6, 2017 · FDA recall Z-3074-2017 · Kentec Medical

Hazard

Inadequate detectability of radiopaque stripes · FDA Class II

Units

K100526

Sold at

TX, VA, IL, CA, KS

Description

Inadequate detectability of radiopaque stripes

Product

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.

Manufacturer(s)

Kentec Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →