Recall Z-1476-2013
Hill-Rom, Inc. · initiated April 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SlingBar Standard. Designed to meet the needs for lifting humans.
Codes / lots: Product #3156011
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.
FDA-determined cause: Device Design
Action taken
On 4/30/13 an URGENT MEDICAL DEVICE RECALL CORRECTION was issued to all consignees detailing the hazards and actions that are needed. Included with this notification is a Response Form/Receipt and a Replacement Guide, complete and return the form to Hill-Rom as soon as possible. Hill-Rom will send you the applicable number of sling bars to you at no cost. After you receive the new sling bars, we request that you discard the old ones.
Details
- Recall number
- Z-1476-2013
- Initiated
- April 30, 2013
- Posted by FDA
- June 5, 2013
- Terminated
- November 28, 2014
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Quantity
- 726
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1473-2013 Class II | SlingBar 350. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1474-2013 Class II | SlingBar 360. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |
| Z-1475-2013 Class II | SlingBar Wide 670. Designed to meet the needs for lifting humans.Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver… | 04/30/2013Terminated |