Z-1353-2021 Class II Terminated
FDA device recall Z-1353-2021 was initiated by Gf Health Products on March 24, 2021 and is designated Class II. Reason for recall: The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. The recall status is terminated (terminated May 1, 2023). Affected quantity: 66 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 24, 2021
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
Drop Arm Versamode"
Reason for Recall
The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Distribution Pattern
Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.
Code Information
Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS