The U.S. Food and Drug Administration has categorized Hillrom’s recall of its Liko Multirall 200 overhead lift as Class I, its most serious level.
Citing its potential for serious harm, the agency said the device was associated with two deaths. Overall, 34 complaints linked to the use of the product were reported, including 22 serious injuries.
To prevent the device from further causing damage to patients, its manufacturer, Hillrom, initiated its recall.
This is not the case, however, for some medical devices in the market. Despite their potential harm, some devices are still being used in patients.
For instance, only a fraction of hernia mesh implants were recalled for medical reasons, despite causing serious complications to patients.
In the United States alone, more than 100,000 hernia mesh devices are implanted each year.
And as expected, many people experienced a wide array of side effects because of the device, including neurological problems, fistulas, and autoimmune diseases, just to name a few.
The affected individuals have started filing Hernia Mesh lawsuits, as the number of plaintiffs still continues to grow as we speak.
In this case, however, the Liko Multirall 200 Overhead Lift recall was designated as Class I for the serious risks it poses to patients in different medical facilities where it is being used.
What Is The Device Used For?
The Liko Multirall 200 Overhead Lift is a general purpose lift that is part of a motorized system which can be used to move patients in a sitting position from room to room.
It has an overhead lift motor, S65 rail carriage hook, and a Q-link strap.
The overhead lift system, which is the subject of the recall, is used in health care settings like hospitals, rehabilitation centers, and nursing homes which have the need to lift and move patients.
Here’s The Reason For Its Class I Recall
Hillrom is recalling the Liko Multirall 200 Overhead Lift because of the risk of its Q-link strap locks not attaching to the S65 carriage hook as they should, the same concern indicated in customer reports linked to the use of the device.
“If the strap lock does not attach, the motor or the patient may fall,” the FDA warning letter stated.
Therefore, use of the affected product could result in adverse events such as serious injury or death.
“Hillrom takes this recall seriously. We are working proactively with our customers to alert them to the field corrective action and ensure their continued safe use of the device as Hillrom continues to implement ongoing corrections to the Liko Multirall 200 product in the field,” a spokesperson for the company told MassDevice via email.
Hillrom Liko Multirall 200 Overhead Lift models affected in the recall include:
- Liko Multirall 200 (product number 3130001)
- Universal SlingBar 450 R2R (product number 3156095)
- Universal SlingBar 350 R2R (product number 3156094)
- Carriage D45 with Double Hook (product number 3136100)
- Extension belt 300-400 mm (product number 3136226)
- Extension belt 400-600 mm (product number 3136227)
- Extension belt 600-1000 mm (product number 3136228)
- Extension belt 1000-1400 mm (product number 3136229)
The recall involves 11,600 devices. The affected products were manufactured between December 2000 and October 2020 and distributed nationwide during the same time period.
What You Can Do
The Chicago-based company initiated the recall by sending a safety notice to affected customers, where it warned them of the potential harm of the product to patients.
Hillrom, known for its hospital beds, ventilators, and other patient care equipment, also told healthcare providers and distributors that it will be replacing the Q-link strap with a Q-link 2 strap in order to prevent risk to both patients and caregivers.
They were also instructed by the company to inspect the Multirall systems in their facilities and identify units impacted by the field corrective action.
If you are a customer wanting to know more about the recall notification, you may contact your local sales representative, or Hillrom Technical Support at (812) 934-7777.
Likewise, medical professionals and consumers may report adverse events linked to the use of this device to the FDA’s Adverse Event Reporting program.