FDA Recall
Terminated
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
Recall: Z-1315-2019
·
Initiated March 28, 2019
Recall
- Recall Number
- Z-1315-2019
- Event Number
- 82571
- FEI Number
- 3001657382
- Product Code
- INM
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 28, 2019
- Terminated
- December 15, 2023
- Address
- R82 A/S Parallelvej 3 Gedved Denmark
Description
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
Reason
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Action
The firm notified the US importer by email on 03/28/2019. The letter explained the problem and requested that the plastic joint connecting the back to the seat base be replaced. The importer will notify the distributors (dealers) of the issue and provide the replacement kits when they arrive. The distributors (dealers) will be performing the field corrections.
Distribution
US in the states of NC
Quantity
68 units