Recall Z-2399-2016
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 w/o mattress & 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 #: BAR600IVC; Serial #s:15BF054037 15BF004216 15BF004217 15BF012364 15EF005762 15EF005763 15EF012120 15EF012121 15GF006881 15BF048555 15DF039686 15DF039687 15LF016359 15LF016361 15HF010997 15HF025587 15HF025588 15IF014204 15IF014205 15IF014206 15IF014207 15IF014208 15IF014209 16AF014283 15DF013421 15DF027839 15DF027840 15DF027841 15DF027842 15EF025665 15EF025676 15HF002806 15HF002807 15HF002808 15HF002809 16BF020092 15IF040576 15JF003246 15KF016696 15KF016697 15LF001343 16AF030663 15EF027538 15EF027541 15JF035242 15JF035243 15JF035244 15JF035245 15JF035246 15LF032425 15LF032426 15GF003764 15JF040948 16AF016782 15DF019105 15DF033803 15DF033804 15EF005756 15EF031153 15EF031163 15EF031164 15EF031165 15DF001325 15EF025678 15FF022339 15FF037337 15HF025599 15IF024195 15IF036443 15LF009178 15LF039840 16AF041543 16AF041549 16BF002993 15LF014902 15FF022337 15BF042553 15BF042554 15CF023283 15CF023284 15DF022408 15DF039689 15DF039690 15DF039691 15JF019607 16BF033772 16BF033773 15BF045966 15LF001337 15IF026992 15IF026996 16AF016787 16AF040813 16BF033768 15EF035410 15EF027548 15EF027549 15FF027574 15DF049778 15DF049779 15DF049783 16BF000448 16BF000449 16BF000450 16BF000451 16AF011604…
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-2399-2016
- Initiated
- March 15, 2016
- Terminated
- September 15, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 2,184 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-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 |
| 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 |