Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
This recall has been terminated (originally issued June 7, 2016).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- March 8, 2016
- Posted
- June 7, 2016
- Terminated
- May 15, 2017
- Recall Number
- Z-1916-2016
- Quantity
- 163,561
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.
Distribution
Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY and ZA.
Lot / Code Info
All Slingbars that are affected by this field action (in the table below) have been distributed within the following serial number range: 1200101 to 1370151 Model Product/Model # Universal SlingBar" 350, 3156074 Universal SlingBar" 350 QRH, 3156084 Universal SlingBar" 350 R2R, 3156094 Universal SlingBar" 450, 3156075 Universal SlingBar" 450 QRH, 3156085 Universal SlingBar" 450 R2R, 3156095 Universal SlingBar" 600 3156076 Universal SlingBar" 600 QRH 3156086
Root Cause
Labeling design
Action Taken
On 3/8/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected US customers via email and courier. On 3/24/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Canadian customers via email and courier. On 3/29/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Global customers via email and Docapost. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification provided new instructions for users with a lift manufactured prior to 11/19/2013, instructed the user on how to inspect for damage, and offers replacement at a 50% reduction in cost. If you have any questions concerning this Field Safety Notice, please contact Hill-Rom Technical Support, your distributor, or your Hill-Rom representative.