Recall Record

Irvine, CA, United States

Kentec Medical, Inc recalls

1 recall recorded since 2018, most recently on 17 January 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
17 January 2020
Terminated
21 October 2022
Reason
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.
Distribution
US: CA, IA, and VA
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2517-2020, Z-2518-2020, Z-2514-2020, Z-2515-2020, Z-2519-2020, Z-2520-2020, Z-2516-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.