Medical Device
Manufacturing
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Z-1451-2014Class II

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and...

Central Purchasing LLC dba Harbor Freight Tools / initiated 2014-03-27 / Terminated

Central Purchasing LLC DBA Harbor Freight Tools began a recall of Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less on . FDA classified it as Class II and gives the reason as "Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1451-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Central Purchasing LLC dba Harbor Freight Tools
Product
Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
Product code
ITJ Walker, Mechanical
Reason for recall
Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.
FDA root cause
Under Investigation by firm
Action
Recall communication to web site customers who purchased the product, notifying them of recall and availability of full refund for product. Store posting notifying retail customers of the recall and availability of full refund for product (with a similar posting provided on the HFT web site). Consumers are informed of the recall, product info. with photo, item number, reason for recall, hazard, instructed to stop using these walkers immediately, and contact information provided telephone number, and e-mail address. Consumer letters also provided with a Merchandise Return Label. On 04/02/14, an updated consumer letter issued.
Quantity in commerce
43,621
Distribution
Nationwide Distribution.
Product codes and lots
SKU/Item Number 66838, Sold June 2009 to March 2014.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1451-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1451-2014Class IITerminatedVoluntary: Firm initiated