FDA Enforcement
Class II
Terminated
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).
Recall: Z-2517-2020
·
Reported July 15, 2020
Enforcement
- Recall Number
- Z-2517-2020
- Event ID
- 85430
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Kentec Medical, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 15, 2020
- Initiation Date
- January 17, 2020
- Classification Date
- July 6, 2020
- Termination Date
- October 21, 2022
- Address
- 17871 Fitch, Irvine, CA, 92614-6001, United States
Description
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).
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.
Code Info
Lot Number: KS1904004
Distribution
US: CA, IA, and VA
Quantity
2130