Recall Z-2401-2016
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 Foot Section for Semi & Full Electric Beds, 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 #: BAR5490IVC; Serial #s: 15BF023716 15CF008150 15JF012488 15JF012489 15JF012490 15BF048545 15BF039458 15BF039459 15BF039460 15BF039461 15BF039462 15BF039463 15BF039464 15BF039465 15BF039466 15BF039467 15BF045955 15BF045956 15CF020336 15CF020337 15CF020338 15CF020339 15CF020340 15CF020341 15CF037863 15DF027823 15DF027824 15DF027825 15DF027826 15DF027827 15DF042103 15DF042105 15DF046695 15EF007464 15EF013525 15EF014826 15EF014827 15EF014828 15GF006921 15GF006925 15GF013384 15GF013385 15GF013386 15GF030883 15GF030885 15GF033318 15HF027020 15HF034771 15HF034775 15HF043300 15HF043301 15IF020130 15IF020131 15IF028759 15IF028760 15IF028761 15IF028762 15IF028763 15IF028764 15IF044966 15IF044967 15IF044968 15IF044969 15KF014068 15KF018077 15LF011111 15LF011112 15LF011113 15LF011114 15LF011115 15LF013140 16AF003847 16AF009018 16AF026282 16AF026283 16AF026284 16AF026285 16AF026286 16AF044630 16BF020098 16BF024626 15AF016197 15AF016198 15BF007602 15AF051670 15BF000847 15AF048735 15AF048736 15AF048737 15AF048738 15AF048739 15AF051666 15BF000861 15CF055428 15DF027818 15AF034671 15BF004206 15BF007603 15FF022340 15AF051103 15LF013148 15LF025830 15BF010331 15BF012341 15BF012342 14LF046072…
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-2401-2016
- Initiated
- March 15, 2016
- Terminated
- September 15, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 3,050 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-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 |