FDA recall Z-0152-2022

Product

smiths medical portex Loss of Resistance Device, REF 100/398/000

Reason for recall

The labeling was missing information on sterilization and prohibition of reuse.

Distribution

Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

Key facts

Status

Terminated

Initiation date

2020-12-08

Report date

2021-10-27

Termination date

2023-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2022