Kentec Medical Inc recalls 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)…

Recall date

June 23, 2017

Source

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

Recall number

Z-3073-2017

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, 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.