Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0155-2007

Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat...

Access Point Medical, LLC / initiated 2006-06-20 / Terminated / root cause: manufacturing process

Access Point Medical LLC began a recall of Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum... on . The reason FDA records is "The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0155-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Access Point Medical, LLC
Product
Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
Product code
ITJ Walker, Mechanical
Reason for recall
The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes.
Root cause tag
manufacturing process
FDA root cause
Other
Action
The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.
Quantity in commerce
Approximately 861 Rollators (total for both models under recalls Z-0154/0155-2007)
Distribution
Nationwide
Product codes and lots
All Rollators of this model number