PlainRecalls
FDA Devices Moderate Class II Terminated

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).

Reported: July 15, 2020 Initiated: January 17, 2020 #Z-2519-2020

Product Description

Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).

Reason for Recall

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.

Details

Recalling Firm
Kentec Medical, Inc
Units Affected
70
Distribution
US: CA, IA, and VA
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).. Recalled by Kentec Medical, Inc. Units affected: 70.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2519-2020.