Z-2445-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2023
- Initiation Date
- June 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 586 devices
Product Description
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
Reason for Recall
Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
Distribution Pattern
US Nationwide distribution.
Code Information
Serial number in the range: 20BHL0002 to 21IHL1910