Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
Brand
Kentec Medical, Inc
Lot Codes / Batch Numbers
Lot Number: KS1711017
Products Sold
Lot Number: KS1711017
Kentec Medical, Inc is recalling Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only due to Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IA, VA
Page updated: Jan 10, 2026