Device Recall Access Point Medical Heavy Duty Rollator with Curved Back 의 리콜

Recall

35919

Class 2

Z-0155-2007

2006-06-20

2006-11-07

Terminated

United States

2008-06-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47147

The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.

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.