Z-3211-2011
Victory 10, 3 Wheel (SC610) Mobility medical device
Pride Mobility Products Corp / initiated 2011-06-22 / Terminated / root cause: manufacturing process
Pride Mobility Products Corp began a recall of Victory 10, 3 Wheel (SC610) Mobility medical device on . The reason FDA records is "Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-3211-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Pride Mobility Products Corp
- Product
- Victory 10, 3 Wheel (SC610) Mobility medical device
- Product code
- INI Vehicle, Motorized 3-Wheeled
- Reason for recall
- Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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. .
- 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.
- Product codes and lots
- Victory 10, 3 Wheel
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