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Recall Observatory FDA recall evidence

Device product

MediChoice Dual-Release Folding Walker with 5" wheel

Z-0416-2015

June 25, 2014

Class II

Product summary

Firm
Owens & Minor Distribution, Inc.
Event
Event 68780
Status
Terminated
Classification
Class II
Quantity
1214 cases; 4 units/case
Official record key
device-enforcement:Z-0416-2015

Official wording

Reason: Product wheels may be too loose, too tight, or fall off.

Code information: Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236;

Distribution pattern: US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product wheels may be too loose, too tight, or fall off.