| Class 2 Device Recall SlingBar Standard | |
Date Initiated by Firm | April 30, 2013 |
Date Posted | June 05, 2013 |
Recall Status1 |
Terminated 3 on November 28, 2014 |
Recall Number | Z-1476-2013 |
Recall Event ID |
64550 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
|
Product | SlingBar Standard.
Designed to meet the needs for lifting humans. |
Code Information |
Product #3156011 |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 1069 State Route 46 East Batesville IN 47006-7520
|
For Additional Information Contact | 812-934-7777 |
Manufacturer 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 2 | Device Design |
Action | 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. |
Quantity in Commerce | 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 Turkey. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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