Z-2516-2020 Class II Terminated
FDA device recall Z-2516-2020 was initiated by Kentec Medical, Inc on January 17, 2020 and is designated Class II. 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 … The recall status is terminated (terminated October 21, 2022). Affected quantity: 710.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- January 17, 2020
- Termination Date
- October 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 710
Product Description
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
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.
Distribution Pattern
US: CA, IA, and VA
Code Information
Lot Number: KS1706021