Recall Z-0231-2024
Breg Inc · initiated September 13, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Codes / lots: Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223
Reason for recall
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
FDA-determined cause: Process design
Action taken
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
Details
- Recall number
- Z-0231-2024
- Initiated
- September 13, 2023
- Posted by FDA
- November 3, 2023
- Product code
- ITJ – Walker, Mechanical
- Quantity
- 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
- Recalling firm
- Breg Inc, Carlsbad, CA