Avanos Medical recalls PEG kits with ENFit connectors due to potential mismatch between retention bolster and tube diameter. Affected kits include specific lot numbers from 2023.
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Avanos Medical is recalling PEG kits with ENFit connectors because the retention bolster might be too large for the tube, which could cause improper fitting. This could lead to complications if the tube isn't secured correctly.
The retention bolster in the kit might be a larger diameter than the tube it's designed to hold. This mismatch could cause the tube to become loose or dislodged during use, potentially leading to complications like leaks or infections.
Patients who have received the specific lot numbers of the PEG kits (8160-20 Lot 30135103 or 8640-20 Lot 30132544) are most at risk. Healthcare providers using these kits for medical procedures may also be affected.
Check the product label for the model code and lot number. Affected kits include Code 8160-20 Lot 30135103 or Code 8640-20 Lot 30132544.
Look for the model code and lot number on the kit packaging or label.
The recalled kits are Code 8160-20 Lot 30135103 or Code 8640-20 Lot 30132544.
The recall record does not mention any remedy or fix for this issue.
The recall indicates a potential mismatch in size that could cause improper tube fitting, but the record does not specify if this leads to serious injury or complications.
We’ve drafted a message you can send Avanos to request your refund or repair — edit it as you like.
Subject: Recall Z-0566-2022 — Avanos Avanos Hello, I own a Avanos that is covered by recall Z-0566-2022 from Avanos. 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.
