Enforcement Report - Week of January 9, 2013
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Event Detail
| Event ID | 62413 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Hill-Rom, Inc. |
| City | Batesville |
| State | IN |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts. | The Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013. Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061. Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035. Packaged with LikoLight up to December of 2004: 2030001 and 2030001H. Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011. Packaged with Caroli lifts up to present: 5011001. | Class II | Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit, and one where a child was playing on a lift and was injured when they tried to jump from the lift. | 261 units | Z-0622-2013 |
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