Z-0656-2022 Class II Terminated
FDA device recall Z-0656-2022 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 February 13, 2023). Affected quantity: 2,816 units (22 cases, 128 per case).
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2022
- Initiation Date
- December 1, 2021
- Termination Date
- February 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,816 units (22 cases, 128 per case)
Product Description
Michels Transport Medium, 20ML Prefilled Cont
Reason for Recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Distribution Pattern
US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.
Code Information
Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023