SlingBar 350. Designed to meet the needs for lifting humans.

FDA device recall Z-1473-2013 · posted 2013-06-05 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

3556

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, Austral

Date initiated

2013-04-30

Date posted

2013-06-05

Date terminated

2014-11-28

Location

Batesville, IN