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Terminated

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

FDA Recall Z-0137-2008 · Posted 2007-12-19

Recalling FirmFreedom Designs Inc
Recall StatusTerminated
Product CodeIOR
Date Initiated2007-05-14
Date Terminated2008-07-14
Product Quantity41 units

Reason for Recall

Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.

Firm 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

Root Cause

Process control

Distribution Pattern

Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060926TRIPODFreedom Designs, Inc. · 2006-05-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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