Kentec Medical recalls Ameritus ENFit feeding tubes due to risk of plastic cap breaking, which may delay feeding and cause unnecessary radiation exposure during x-rays.
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 used to confirm tube placement.
The plastic tethered closure cap on the feeding tube could fracture or break during use. If this happens, feeding and medication administration might be delayed until a new tube is placed. Additionally, if x-rays are used to confirm tube placement after a break, the patient could receive unnecessary radiation exposure.
Patients using feeding tubes for enteral nutrition or medication administration are most at risk. Healthcare providers who use these tubes for medical care may also be affected.
Check for the catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port) on the tube. The lot number KS1810008 is also associated with this recall.
Inspect the plastic tethered closure cap for signs of cracking or damage.
Reach out to Kentec Medical for guidance on next steps if the cap appears damaged.
The plastic tethered closure cap may fracture or break, which could delay feeding or medication administration and cause unnecessary radiation exposure if x-rays are used to confirm tube placement.
If the cap breaks, contact Kentec Medical for guidance on replacing the tube safely.
Yes, the affected models are the ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port) with lot number KS1810008.
We’ve drafted a message you can send Kentec Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2518-2020 — Kentec Medical Kentec Medical Hello, I own a Kentec Medical that is covered by recall Z-2518-2020 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.