Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0781-2014Class II

TopCare Clifford THE BIG RED DOG power toothbrush for kids!

Ranir LLC / initiated 2013-12-18 / Terminated / root cause: design

Ranir Corporation began a recall of TopCare Clifford THE BIG RED DOG power toothbrush for kids! 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-0781-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ranir LLC
Product
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
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 071031069496, all lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0781-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0781-2014Class IITerminatedVoluntary: Firm initiated
Z-0782-2014Class IITerminatedVoluntary: Firm initiated