FDA recall Z-0147-2025
Smiths Medical ASD Inc. · Class II · device
Product
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Reason for recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution
Worldwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-07-18
- Report date
- 2024-10-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2025