Recall Z-2402-2016
Invacare Corporation · initiated March 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Codes / lots: Model #'s:1104343 & 1104345
Reason for recall
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
FDA-determined cause: Nonconforming Material/Component
Action taken
Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance.
Details
- Recall number
- Z-2402-2016
- Initiated
- March 15, 2016
- Terminated
- September 15, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 1,011 units
- Distribution
- US Nationwide Distribution including DC and PR. Internationally Canada.
- Recalling firm
- Invacare Corporation, Elyria, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2399-2016 Class II | Invacare Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare…The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They… | 03/15/2016Terminated |
| Z-2400-2016 Class II | Invacare Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The…The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They… | 03/15/2016Terminated |
| Z-2401-2016 Class II | Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The…The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They… | 03/15/2016Terminated |