FDA recall Z-0163-2022
Smiths Medical ASD Inc. · Class III · device
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Reason for recall
Two devices were labeled with the same serial number
Distribution
UK
Key facts
- Status
- Terminated
- Initiation date
- 2021-07-15
- Report date
- 2021-11-03
- Termination date
- 2023-08-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2022