Kentec Medical recalls Ameritus ENFit feeding tubes due to risk of plastic cap breaking, which may delay feeding and cause unnecessary radiation exposure during tube placement checks.
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.
Kentec Medical is recalling Ameritus ENFit Polyurethane and Silicone Feeding Tubes because the plastic tethered closure cap might break. This could delay feeding or cause unnecessary radiation exposure if x-rays are needed to confirm tube placement.
The plastic cap that holds the tube securely could break during use. If it breaks, feeding might be delayed until a new tube is placed. Additionally, if x-rays are used to check tube placement, the patient could receive unnecessary radiation exposure.
Patients using these feeding tubes for enteral nutrition are most at risk. Healthcare providers who administer these tubes through medical procedures may also be affected.
Check for catalog number ENF-60P-50 (6 tubes, 50 cm length) on the tube packaging. The lot number KS1706021 is also associated with this recall.
Look for catalog number ENF-60P- 50 (6 tubes, 50 cm length) and lot number KS1706021 on the packaging.
The plastic tethered closure cap may break, which could delay feeding or cause unnecessary radiation exposure if x-rays are needed to confirm tube placement.
Check the tube packaging for catalog number ENF-60P-50 and lot number KS1706021. If it matches, stop using it and contact Kentec Medical for instructions.
The recall states possible delays in feeding and unnecessary radiation exposure, but does not mention serious injury risks.
We’ve drafted a message you can send Kentec Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2516-2020 — Kentec Medical Kentec Medical Hello, I own a Kentec Medical that is covered by recall Z-2516-2020 from Kentec Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.