Z-0148-2022 Class II Terminated
FDA device recall Z-0148-2022 was initiated by Smiths Medical ASD Inc. on July 14, 2020 and is designated Class II. Reason for recall: Product may have been manufactured with an air filter assembled in an incorrect orientation. The recall status is terminated (terminated August 4, 2023). Affected quantity: 371 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- July 14, 2020
- Termination Date
- August 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 371 units
Product Description
CADD Administration Sets, Model #21-7346-24
Reason for Recall
Product may have been manufactured with an air filter assembled in an incorrect orientation.
Distribution Pattern
Canada
Code Information
Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669