Home / Recalls / Medical Devices
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-
Recalled September 6, 2017 · FDA recall Z-3073-2017 · Kentec Medical
Hazard
Inadequate detectability of radiopaque stripes · FDA Class II
Units
54 boxes of 10 individual units
Sold at
TX, VA, IL, CA, KS
Description
Inadequate detectability of radiopaque stripes
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.
Manufacturer(s)
Kentec Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →