FDA-Device2020-07-15Class II
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
Kentec Medical, Inc
Hazard
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Sold states
US: CA, IA, and VA
Affected count
2130
Manufactured in
17871 Fitch, Irvine, CA, United States
Products
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2020Don't want to check this manually?
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