Device Recall Access Point Quad Canes 의 리콜

Recall

35920

Class 2

Z-0204-2007

2006-03-10

2006-11-22

Terminated

United States

2008-04-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47151

The canes were made of unacceptable materials and could break.

The firm began making telephone calls and issuing recall letters dated 3/9/06 via UPS on 3/10/06. The telephone call explained the reason for recall and notified the customer they would be receiving a letter requesting return of the canes. The letter additionally notified the customer the recall was to be affected to the retail level. A customer response form was enclosed. The firm issued a second recall letter dated 12/22/06 via registered mail on 12/26/06 explaining the reason for recall, pointing out the hazard involved with the use of the recalled canes, and requesting they cease sales of the product. The letter requested they notify their customers of the recall and to post the enclosed recall placard where it can be seen by returning customers. Recall instructions were enclosed outlining step-by-step instructions for their customer to follow, including destroying the canes on site. A Customer Response Form was also enclosed. The firm issued a third letter dated 1/11/07 via regular mail which included a corrected placard because the product code numbers were incorrect in the placard included with the letter dated 12/22/06. The customers were instructed to discard the previous placard.