FDA recall Z-0099-2022
Smiths Medical ASD Inc. · Class II · device
Product
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Reason for recall
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Distribution
Austria, France, Germany, Great Britain, and Saudi Arabia
Key facts
- Status
- Terminated
- Initiation date
- 2020-03-10
- Report date
- 2021-10-20
- Termination date
- 2023-09-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2022