Z-0163-2022 Class III Terminated
FDA device recall Z-0163-2022 was initiated by Smiths Medical ASD Inc. on July 15, 2021 and is designated Class III. Reason for recall: Two devices were labeled with the same serial number The recall status is terminated (terminated August 11, 2023). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 3, 2021
- Initiation Date
- July 15, 2021
- Termination Date
- August 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Reason for Recall
Two devices were labeled with the same serial number
Distribution Pattern
UK
Code Information
SN RF70121