Atos Medical recalls Provox Life Night HME heat and moisture exchangers (catalog 8262) due to potential stoma blockage from incorrect insertion. Affected units: lot numbers 2012158 and 2012124.
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Atos Medical is recalling Provox Life Night HME single-use heat and moisture exchangers because they might block a patient's stoma if inserted incorrectly. This could cause breathing problems for people using tracheostomies.
The device may be inserted sideways or forced through the adhesive coupling, which could block the stoma. This blockage might prevent proper breathing for patients with tracheostomies.
Patients using tracheostomies with this specific product are most at risk. The recall affects only those with the listed lot numbers.
Check the lot number on the product label. Affected units have lot numbers 2012158 or 2012124. This product is a single-use heat and moisture exchanger for tracheostomy patients.
Look for lot numbers 2012158 or 2012124 on the device label.
The Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling, potentially blocking the stoma.
Check the lot number on the device label. Affected units have lot numbers 2012158 or 2012124.
The recall does not require immediate discontinuation; check the lot number to see if your unit is affected.
We’ve drafted a message you can send Atos Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1548-2021 — Atos Medical Atos Medical Hello, I own a Atos Medical that is covered by recall Z-1548-2021 from Atos 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.
