Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0137-2008

Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod...

Freedom Designs Inc / initiated 2007-05-14 / Terminated / root cause: manufacturing process

Freedom Designs Inc began a recall of Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link... on . The reason FDA records is "Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0137-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Freedom Designs Inc
Product
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065
Product code
IOR Wheelchair, Mechanical
Reason for recall
Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Urgent Field Correction Notification letters were sent to customers on May 15, 2007 via US Postal return receipt requested. Consignees were notified via delivery of a field correction package consisting of: (1) A letter to the dealer (2) FAQ sheet clarifying their responsibility (3) A corrective/preventive action tracking sheet specific for the consignees affected units (4) Replacements of anti-tipper assembly for each unit shipped with an instruction sheet. A Notice was also posted on the Freedom Designs website. Correction will be made to the consumer level
Quantity in commerce
41 units
Distribution
Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA
Product codes and lots
Serial numbers: LTP-90088, LTP-90090, LTP-90092, LTP-90095, LTP-90105, LTP-90106, LTP-90107, LTP-90108, LTP-90109, LTP-90110, LTP-90111, LTP-90112, LTP-90113, LTP-90114, LTP-90115, LTP-90117, LTP-90118,  LTP-90119, LTP-90122, LTP-90127, LTP-90130, LTP-90131, LTP-90134, LTP-90135, LTP-90136, LTP-90138, LTP-90139, LTP-90140, LTP-90141, LTP-90142, LTP-90143, LTP-90146, LTP-90147, LTP-90149, LTP-90150,  LTP-90151, LTP-90152, TP-30153, TP-30013, TP-30025, TP-30136