Atos Medical AB Kraftgatan Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Brand
Atos Medical AB Kraftgatan
Lot Codes / Batch Numbers
Lot Numbers: 2012158 and 2012124
Products Sold
Lot Numbers: 2012158 and 2012124
Atos Medical AB Kraftgatan is recalling Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchange due to Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Recommended Action
Per FDA guidance
Atos Medical initiated the recall by telephone and email on 03/29/2021 to the medical facilities. The firm followed with a letter mailed (USPS) on 04/01/2021. The firm will begin contacting the patients the week of April 5, 2021 to confirm receipt of the letter, confirm understanding of the correct use, and answer any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026