BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Summary
The FDA issued a Class II for BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking a by Breg Inc. Reason: Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels..
Details
Source
Device Recall
External ID
Z-0231-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Lot/Code Info: Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223
Quantity Affected: 11,193 units
Reason for Recall
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-13
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Breg Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breg Inc have FDA actions?
This is the only FDA action we have on record for Breg Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0231-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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