Z-0554-2022 Class II Terminated
FDA device recall Z-0554-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on December 1, 2021 and is designated Class II. Reason for recall: Product stored incorrectly in temperature controlled setting instead of refrigeration. The recall status is terminated (terminated January 9, 2023). Affected quantity: 100 units (4 packs, 25 per pack).
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 1, 2021
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units (4 packs, 25 per pack)
Product Description
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Reason for Recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Distribution Pattern
US Nationwide distribution in the state of California.
Code Information
Model Number HADZ110, all lots