Z-0932-2022Class II
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-03-08 / Terminated
MEDLINE INDUSTRIES, LP - Northfield began a recall of Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL) on . FDA classified it as Class II and gives the reason as "Product was improperly store which may cause a delay in results". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0932-2022
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
- Product code
- JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
- Reason for recall
- Product was improperly store which may cause a delay in results.
- FDA root cause
- Storage
- Action
- Consignees were notified via first class mail on March 08, 2022. Consignees are responsible for initiating sub-recalls, where necessary. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to Medline.
- Quantity in commerce
- 45 ea
- Distribution
- US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
- Product codes and lots
- Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0932-2022 | Class II | Terminated | Voluntary: Firm initiated |
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