Kentec Medical recalls Ameritus ENFit feeding tubes due to risk of cap fracture causing feeding delays or unnecessary radiation exposure from 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 cap could break, potentially delaying feeding or requiring extra x-rays to confirm tube placement. This poses a risk to patients needing enteral feeding.
The feeding tube's plastic tethered closure cap may fracture or break during use. If the cap breaks, it could delay feeding or cause the tube to shift, requiring additional x-rays to confirm proper placement. This might lead to unnecessary radiation exposure for the patient.
Patients using enteral feeding tubes are most at risk. The recall affects individuals with medical conditions requiring tube feeding, such as those with swallowing difficulties or gastrointestinal issues.
Check for the catalog number ENF-Y50P-80 on the tube packaging. The tubes are sterile and single-use only, sold with a lot number starting with KS1811009.
Look for the catalog number ENF-Y50P-80 and lot number starting with KS1811009 on the tube packaging.
The plastic tethered closure cap may fracture or break, potentially delaying feeding or requiring additional x-rays to confirm tube placement.
If the cap breaks, it could delay feeding until a new tube is placed, or cause unnecessary radiation exposure from x-rays if the tube's placement needs confirmation.
Check for the catalog number ENF-Y50P-80 and lot number starting with KS1811009 on the tube packaging.
We’ve drafted a message you can send Kentec Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2519-2020 — Kentec Medical Kentec Medical Hello, I own a Kentec Medical that is covered by recall Z-2519-2020 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.