Z-0782-2014Class II
UP & UP kids' power toothbrush
Ranir LLC / initiated 2013-12-18 / Terminated / root cause: design
Ranir Corporation began a recall of UP & UP kids' power toothbrush on . FDA classified it as Class II and gives the reason as "Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0782-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ranir LLC
- Product
- UP & UP kids' power toothbrush
- Product code
- JEQ Toothbrush, Powered
- Reason for recall
- Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Ranir, LLC phoned their two direct accounts notifying them of this recall on December 12, 2013. On December 18, 2013, Ranir, LLC sent an URGENT: MEDICAL DEVICE RECALL notification letter was sent to their direct accounts. The notification stated the affected product, issue, and instructions for responding to the notification, including instructions for return of the affected product. Questions are directed to Paula Bojsen (616)698-8880.
- Quantity in commerce
- 601,616 total
- Distribution
- Distributed in MN and IL.
- Product codes and lots
- UPC 071031015523, all lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0781-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0782-2014 | Class II | Terminated | Voluntary: Firm initiated |
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