Recall Z-0274-2016
Hill-Rom, Inc. · initiated October 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Codes / lots: Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299
Reason for recall
Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
FDA-determined cause: Device Design
Action taken
Hill-Rom initiated Phase 1 of the recall on October 2, 2015, which included notices of the recall being issued to customers via certified mail, which included safety information on how to properly use the bed, and instructions to forward the information on if devices have been transferred. Phase 2 for the recall will include the distribution of caps for the edges of the bed to be placed on by the customers. Customers may contact Hill-Rom Technical Support at 800-445-3720.
Details
- Recall number
- Z-0274-2016
- Initiated
- October 7, 2015
- Posted by FDA
- November 13, 2015
- Terminated
- February 10, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 12251 units
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN