Recall Z-0096-2021— Handicare AB
Class II · Terminated
Class II FDA medical device recall by Handicare AB, initiated 2020-08-21, terminated 2023-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.. Reason: Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component..
- Recalling firm
- Handicare AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-21
- Terminated
- 2023-01-30
- Firm location
- Lulea, N/A, Sweden
Product description
SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.
Reason for recall
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Data sourced from openFDA. This site is unofficial and independent of the FDA.