Recall Z-2520-2020 ยท FPD Tube, Feeding
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
| Date | Jan 17, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 170 |
| Distribution | US: CA, IA, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE Kentec Medical, Inc., Apr 22, 2010 |