FDA recall Z-1504-2021

Merits Holdings Co. dba Merits Health Products, Inc. · Class II · device

Product

Power Wheelchair

Reason for recall

Seat baseplate pin has broken in the field.

Distribution

Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada

Key facts

Status
Ongoing
Initiation date
2021-04-01
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Myers, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2021