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Class 2 Device Recall Provox Life Night HME |
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| Date Initiated by Firm |
March 29, 2021 |
| Create Date |
May 10, 2021 |
| Recall Status1 |
Terminated 3 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 |
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 2 |
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
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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.
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