FDA recall Z-0095-2022

Smiths Medical ASD Inc. · Class II · device

Product

smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

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-0095-2022