Device product
Premier Rotaclone, Rx only
Z-0552-2022
Product summary
- Event
- Event 89165
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 units
- Official record key
device-enforcement:Z-0552-2022
Official wording
Reason: Product stored incorrectly in temperature controlled setting instead of refrigeration.
Code information: Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023
Distribution pattern: US Nationwide distribution in the states of California and Massachusetts.
Derived failure modes
-
Unknown
Product stored incorrectly in temperature controlled setting instead of refrigeration.