Recall Z-2400-2016
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
Invacare Bariatric Bed with mattress and rails , 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 #: BARPKGIVC-1633; Serial #s: 15BF015617 15BF015618 15IF040586 15LF007886 15LF030500 15IF044964 15JF027523 15DF039684 15IF000656 15JF039196 15LF025841 15GF013405 15IF001676 15IF003788 15IF028783 15IF028784 15JF010270 15JF014683 15KF033384 16AF011108 15LF003819 16AF024508 16AF024509 15BF015622 15BF024675 15BF024678 15DF001324 15DF011345 15DF016457 15DF038243 15DF038244 15FF043818 15FF043822 15GF013418 15GF013419 15GF030895 15IF022355 15BF015626 15BF018543 15BF018544 15BF018545 15BF018546 15BF018547 15BF019841 15BF015624 15BF031157 15CF035105 15CF035106 15EF028981 15GF011720 15GF011721 15BF010327 15BF015640 15CF037855 15CF037856 15CF037857 15DF006120 15DF006121 15DF006122 15DF006123 15EF037541 15EF037542 15GF006873 15LF016357 15DF031032 15LF023497 16AF014286 16AF014287 15EF027547 15EF027552 15CF001424 15CF001425 15DF038252 15DF038253 15BF007598 15BF007599 15BF007600 15CF008156 15CF024415 15CF024416 15CF024417 15CF024418 15CF048563 15CF048564 15CF048565 15DF011352 15FF043823 15FF043826 15FF043827 15KF009783 15KF009784 15KF009785 15LF023499 15LF025846 16BF020108 16BF020109 16BF020110 16BF022580 16BF022581 16BF022582 15CF035118 15CF048566 15CF035123 15CF055440 15IF026984…
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-2400-2016
- Initiated
- March 15, 2016
- Terminated
- September 15, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 2,702 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-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 |
| Z-2402-2016 Class II | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to…The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They… | 03/15/2016Terminated |