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-Y60P-…

Recall date

June 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3074-2017

FDA classification

Class II

Brand / firm

Kentec Medical Inc

Sold / distributed

TX, VA, IL, CA, KS

Why it was recalled

Inadequate detectability of radiopaque stripes

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.