Handicare SwiftHook Component Recall for Mobile and Ceiling Lifts
Handicare AB is recalling SwiftHook components used in mobile and ceiling lifts because the carry bar may detach during use, posing a risk of injury to patients and caregivers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (carry bar detachment) in a medical device used for patient positioning, which poses a significant risk of injury.
Plain-English summary
Handicare AB is recalling the SwiftHook component, which is sold individually and included with Vega505EE mobile lifts. The recall affects 6,716 units, with 585 units distributed in the United States and 6,131 units distributed outside the US. The product is intended to assist people with functional impairments in scenarios involving physical positioning.
The recall is being issued because the carry bar may detach during use of mobile lifts and ceiling lifts equipped with the SwiftHook component. This defect could result in the loss of support for the patient or equipment, creating a hazard for users.
Affected units include model numbers 70200008 and 60600003. Specific serial numbers and sales order numbers are listed in the official recall documentation. Consumers and healthcare facilities should stop using the affected SwiftHook components immediately and contact Handicare AB for instructions on repair or replacement.
The recalled product
- 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.
- Manufacturer
- Handicare AB
- Category
- Medical Device — Patient Lifts
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. Model number: 70200008
- b. Model number: 60600003
- Serial Numbers 660311979
- 660311759
- 010733176902042221660312235
- 660311299
- 660312299 660311338
- 7331769020422
- 660311817
- 660311846
- 660311847
- 660311848
- 6603118540422
- 660311855
- 6603118560422
- 660311849
- 660311850
- 660311851
- 660311852
- 660311877
Distribution
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