Z-0552-2022 Class II Terminated
FDA device recall Z-0552-2022 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: 34 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 1, 2021
- Termination Date
- February 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
Product Description
Premier Rotaclone, Rx only
Reason for Recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Distribution Pattern
US Nationwide distribution in the states of California and Massachusetts.
Code Information
Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023