Reported May 19, 2021 · Terminated

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients…

Atos Medical AB

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Atos Medical AB · Kraftgatan 8 · Horby · N/A

Is this the product you have?

  • Provox Life Night HME
  • Catalogue Number 8262 - Product Usagesingle use heat and moisture exchangers for patients breathing through a tracheostoma
Lot codes and dates
  • Lot Numbers2012158 and 2012124
Amount recalled
225 boxes of 30 devices

Where it was sold

Why it was recalled

Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Atos Medical AB recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 17, 2022 · Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.