Recall record at a glance
| Official record | Z-0096-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Handicare AB |
| Report date | Oct 21, 2020 |
| Recall initiation date | Aug 21, 2020 |
| Quantity | 6716 units (585 in US; 6131 in OUS) |
| Location | Lulea, N/A, Sweden |
Official 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.
Why the product was recalled
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Distribution information
Worldwide distribution - US Nationwide distribution including in the states of CA, IL, MD, MI, MN, NH, NJ, NY, ON, PA, TX, VA, WA, WI and the countries of Australia, Belgium, Canada, Chile, Denmark, Finland, Germany, Iceland, Ireland, Israel, Japan, Lithuania/ Lathvia, Malaysia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Spain, Sweden, Taiwan the Netherlands, UAE, UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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