Class 2 Device Recall BREG Walker

• Date Initiated by Firm: September 13, 2023
• Date Posted: November 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0231-2024
• Recall Event ID: 93114
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
• Code Information: Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223
• Recalling Firm/ Manufacturer: Breg Inc; 2382 Faraday Ave; Carlsbad CA 92008-7218
• For Additional Information Contact: 760-795-5440
• Manufacturer Reason for Recall: Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
• FDA Determined Cause: Process design
• Action: On 09/13/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customer informing them that folding walkers distributed between June 2023 to August 2023 did not meet product specifications for wheel alignment. Products exhibit: -Misalignment of wheels may result in immobility of walker -Misalignment of wheels may result in obstruction of glide/roll Customers are instructed to: -Immediately examine their inventory and quarantine products subject to this recall -For devices separated from labeling, visual examination of devices may be required. The misalignment looks like the wheels are not parallel to each other. -Segregate product with misaligned wheels and return to Breg via Return Material Authorization (RMA or Return Inventory (RI) process. -Review and fill out the response form and return to Breg. For questions, email to bregfieldcorrection@breg.com
• Quantity in Commerce: 11,193 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.