SlingBar 350. Designed to meet the needs for lifting humans.
FDA Device Recall #Z-1473-2013 — Class II — April 30, 2013
Recall Summary
| Recall Number | Z-1473-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 30, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hill-Rom, Inc. |
| Location | Batesville, IN |
| Product Type | Devices |
| Quantity | 3556 |
Product Description
SlingBar 350. Designed to meet the needs for lifting humans.
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.
Distribution Pattern
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.
Lot / Code Information
3156015, 3156002, 3156008' 3156004
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.