Atos Medical AB Recall 87635
Description: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Atos Medical AB Recall 87635 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1548-2021 |
| Event ID | 87635 |
| Event Description | Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| Product Type | 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. |
| Quantity | 225 boxes of 30 devices |
| Recall Reason | Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. |
| Device Classification | 20210519 |
| Device Code Info | Lot Numbers: 2012158 and 2012124 |
| Center Classification Date | 20210510 |
| Recall Initiation Date | 20210329 |
| Recalling Firm | Atos Medical AB |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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