Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal S...
FDA Device Recall #Z-1916-2016 — Class II — March 8, 2016
Recall Summary
| Recall Number | Z-1916-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hill-Rom, Inc. |
| Location | Batesville, IN |
| Product Type | Devices |
| Quantity | 163,561 |
Product Description
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).
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 Pattern
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 Information
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
Other Recalls from Hill-Rom, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0783-2022 | Class II | (1)Traverse Rail Carrier E-System, wide 31017XX... | Jan 14, 2022 |
| Z-0639-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-0640-2022 | Class II | Liko Mobile Lifts: Primarily intended for use i... | Dec 23, 2021 |
| Z-2600-2021 | Class II | LikoStretch 1900 Model Number: 3156051 - The co... | Aug 11, 2021 |
| Z-2599-2021 | Class II | Stretch Leveller Model Number: 3156200 - The co... | Aug 11, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.