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).
Recall
- Recall Number
- Z-2519-2020
- Event Number
- 85430
- Firm
- Kentec Medical, Inc
- FEI Number
- 2080225
- Product Code
- FPD
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 17, 2020
- Terminated
- October 21, 2022
- Address
- 17871 Fitch, Irvine, CA, 92614-6001
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).
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.
On 01/02/2020, the firm notified affected customers via mail of "'URGENT' VOLUNTARY RECALL NOTICE". The letter indicated to IMMEDIATELY stop use of affected product and to move affected product to a location that prevents potential use. Contact the firm immediately, via the phone number (800-825-5996) or email to arrange return of the affected product. Complete and sign the attached Voluntary Recall Response Form, to acknowledge the receipt and understanding of the content incorporated. Return completed form within five (5) business days to the firm.
US: CA, IA, and VA
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