Recall Z-1548-2021 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Atos Medical AB
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
| Date | Mar 29, 2021 |
| Status | Terminated |
| Reason | Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.