FDA Device recall Z-0552-2022
Premier Rotaclone, Rx only
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Premier Rotaclone, Rx only by Medline Industries Northfield, citing product stored incorrectly in temperature controlled setting instead of refrigeration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0552-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-01 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Premier Rotaclone, Rx only
Reason
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Identifiers
| code_info | Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.