FDA (Devices) recall action 64550
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hill-Rom is recalling 412 SlingBar Wide 670 patient lifts because a retrospective review found a potential for impalement if a person falls onto the hooks.
Hill-Rom is recalling 726 SlingBar Standard units because a retrospective review found a potential for impalement if a person falls onto the hooks.
Hill-Rom is recalling 3,556 SlingBar 350 patient lifting devices because a retrospective review found four units may present a potential for impalement if a person falls onto the hooks.
Hill-Rom is recalling 16 SlingBar 360 patient lifting devices because a retrospective review found a potential for impalement if a person falls onto the hooks.