Class 2 Device Recall Provox Life Night HME

• Date Initiated by Firm: March 29, 2021
• Create Date: May 10, 2021
• Recall Status: Terminated on February 17, 2022
• Recall Number: Z-1548-2021
• Recall Event ID: 87635
• Product Classification: Condenser, heat and moisture (artificial nose) - Product Code BYD
• Product: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
• Code Information: Lot Numbers: 2012158 and 2012124
• FEI Number: 3002806269
• Recalling Firm/ Manufacturer: Atos Medical AB; Kraftgatan 8; Horby Sweden
• Manufacturer Reason for Recall: Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 225 boxes of 30 devices
• Distribution: US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.