Recall Z-1473-2013— Hill-Rom, Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom, Inc., initiated 2013-04-30, terminated 2014-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: SlingBar 350. Designed to meet the needs for lifting humans.. Reason: 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..
- Recalling firm
- Hill-Rom, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-30
- Terminated
- 2014-11-28
- Firm location
- Batesville, IN, United States
Product description
SlingBar 350. Designed to meet the needs for lifting humans.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.