Premier Rotaclone — Class II medical device recall Z-0552-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-02-09, distributed nationwide. Product stored incorrectly in temperature controlled setting instead of refrigeration.
| Recall number | Z-0552-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2021-12-01 |
| Classified | 2022-02-02 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2023-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 34 units |
| Reason classes | temperature control |
| Lot numbers | 696004N116 |
| Model numbers | RID696004 |
| Expiration dates | 2023-01-12 |
Product
Premier Rotaclone, Rx only
Reason for recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.