Z-1548-2021 Class II Terminated
FDA device recall Z-1548-2021 was initiated by Atos Medical AB on March 29, 2021 and is designated Class II. Reason for recall: Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. The recall status is terminated (terminated February 17, 2022). Affected quantity: 225 boxes of 30 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 29, 2021
- Termination Date
- February 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225 boxes of 30 devices
Product Description
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Reason for Recall
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Distribution Pattern
US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Code Information
Lot Numbers: 2012158 and 2012124