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Recall Observatory FDA recall evidence

Device product

Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)

Z-0204-2015

October 01, 2014

Class II

Product summary

Firm
Roscoe Medical Inc
Event
Event 69367
Status
Terminated
Classification
Class II
Quantity
831 units
Official record key
device-enforcement:Z-0204-2015

Official wording

Reason: The caster may separate completely from the device frame causing injury to user.

Code information: 30194, Roscoe Transport Rollator, Blue 30192, Roscoe Transport Rollator, Burgundy MH140401502-MH140401890 MH140500217-MH140500466 MH140406602-MH140406891 MH140407092-MH140407291

Distribution pattern: Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The caster may separate completely from the device frame causing injury to user.