FDAFDA · Food and drugs·Recall number Z-2517-2020
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).
Published July 15, 2020 · Recall initiated: January 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kentec Medical, Inc
- Distributor
- US: CA, IA, and VA
- Lot
- Lot Number: KS1904004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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