Recall Z-1943-2020— Handicare AB
Class II · Ongoing
Class II FDA medical device recall by Handicare AB, initiated 2016-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: EVA Floor Lifts, Model Numbers: 400, 450, 600. Reason: After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer..
- Recalling firm
- Handicare AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2016-06-15
- Firm location
- Lulea, N/A, Sweden
Product description
EVA Floor Lifts, Model Numbers: 400, 450, 600
Reason for recall
After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.