Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and Small Base - Chrome, Product Code C

FDA device recall Z-0204-2007 · posted 2006-11-22 · Terminated

Recall details

Recalling firm

Access Point Medical LLC

Reason for recall

The canes were made of unacceptable materials and could break

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IPS

Quantity affected

130/6-cane cases

Distribution

Nationwide.

Date initiated

2006-03-10

Date posted

2006-11-22

Date terminated

2008-04-24

Location

St. Louis, MO