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Recall Observatory FDA recall evidence

Device product

BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

Z-0231-2024

September 13, 2023

Class II

Product summary

Firm
Breg Inc
Event
Event 93114
Status
Ongoing
Classification
Class II
Quantity
11,193 units
Official record key
device-enforcement:Z-0231-2024

Official wording

Reason: Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

Code information: Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223

Distribution pattern: U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.