PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 27, 2021 Initiated: December 8, 2020 #Z-0152-2022

Product Description

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.

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
3420 devices
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
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
smiths medical portex Loss of Resistance Device, REF 100/398/000. Recalled by Smiths Medical ASD Inc.. Units affected: 3420 devices.
Why was this product recalled?
The labeling was missing information on sterilization and prohibition of reuse.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0152-2022.