Z-0100-2022 Class II Terminated
FDA device recall Z-0100-2022 was initiated by Smiths Medical ASD Inc. on March 10, 2020 and is designated Class II. Reason for recall: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. The recall status is terminated (terminated September 22, 2023). Affected quantity: 20800 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- March 10, 2020
- Termination Date
- September 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20800 units
Product Description
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Reason for Recall
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Distribution Pattern
Austria, France, Germany, Great Britain, and Saudi Arabia
Code Information
All codes