Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0521-06

The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue...

Tung Keng Enterprise Co., Ltd. / initiated 2005-11-01 / Terminated

Tung Keng Enterprise Co., Ltd. began a recall of The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU... on . The reason FDA records is "The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0521-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Tung Keng Enterprise Co., Ltd.
Product
The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.
Product code
INI Vehicle, Motorized 3-Wheeled
Reason for recall
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
FDA root cause
Other
Action
The recalling firm sent field correction instructions to their customers on or about 11/1/05.
Quantity in commerce
8,213 total devices
Distribution
The product was distributed to OHL/Invacare, Rancho Technology Park Bldg. B 8950, Rancho Cucamonga, CA 91730; OHL/Invacare, 1100 Whitaker Road, Plainfield, IN 46168; Invacare Corporation, 39400 Taylor Parkway North Ridgeville, OH 44039; and Invacare, Dallas Texas Distribution Center, 3460 South Watson Rd., Arlington, TX 76014.
Product codes and lots
All serial numbers 04H86001 to 05A468246.