Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-0152-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 8, 2020

Date Posted: October 27, 2021

Recall Number: Z-0152-2022

Event ID: 88741

Reason for Recall:

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

Status: Terminated

Product Quantity: 3420 devices

Code Information:

Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated