FDA recall Z-0093-2022

Product

smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1

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-0093-2022