Recall Z-3212-2011

Pride Mobility Products Corp · initiated June 22, 2011

Terminated

Product

Victory 10, 4 Wheel (SC710) Mobility medical device

Codes / lots: Victory 10, 4 Wheel (SC710)

Reason for recall

Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.

FDA-determined cause: Nonconforming Material/Component

Action taken

Pride Mobility Products Corp. sent a "RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .

Details

Recall number
Z-3212-2011
Initiated
June 22, 2011
Posted by FDA
September 14, 2011
Terminated
November 20, 2014
Product code
INI – Vehicle, Motorized 3-Wheeled
Distribution
Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Australia, Canada, France, and United Kingdom.
Recalling firm
Pride Mobility Products Corp, Exeter, PA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3211-2011 Victory 10, 3 Wheel (SC610) Mobility medical deviceContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in… 06/22/2011Terminated