Z-0152-2022 Class II Terminated
FDA device recall Z-0152-2022 was initiated by Smiths Medical ASD Inc. on December 8, 2020 and is designated Class II. Reason for recall: The labeling was missing information on sterilization and prohibition of reuse. The recall status is terminated (terminated August 4, 2023). Affected quantity: 3420 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- December 8, 2020
- Termination Date
- August 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3420 devices
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.
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
Code Information
Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003