Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Reported: May 19, 2021 Initiated: March 29, 2021 #Z-1548-2021
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.
Details
- Recalling Firm
- Atos Medical AB
- Units Affected
- 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.
- Location
- Horby
Frequently Asked Questions
What product was recalled? ▼
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.. Recalled by Atos Medical AB. Units affected: 225 boxes of 30 devices.
Why was this product recalled? ▼
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1548-2021.
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