Over 11K Hillrom Multirall Patient Lifts Recalled Following 22 Injuries And 2 Deaths
A Class I recall was announced by health officials of the Food and Drug Administration (FDA) for Hillrom’s electric patient lifts, which are commonly found and used in hospitals and care facilities.
This recall came after 34 complaints were reported against the product, which was linked to 22 injuries and 2 deaths.
The patient lifts included in the recall are:
- Hillrom Liko Multirall 200 (product # 3130001)
- Universal SlingBar 450 R2R (product # 3156095)
- Universal SlingBar 350 R2R (product # 3156094)
- Carriage D45 with Double Hook (product # 3136100)
- Extension belt 300-400 mm (product # 3136226)
- Extension belt 400-600 mm (product # 3136227)
- Extension belt 600-1000 mm (product # 3136228)
- Extension belt 1000-1400mm (product # 3136229)
FDA ha recalled these lifts, particularly those that are manufactured from December 2000 to October 2020 and with distribution dates of December 17, 2000, to October 1, 2020.
There are a total of 11,600 patient lift devices recalled in the U.S.
According to Hillrom, the Multirall™ 200 overhead lift system is being used as a portable overhead lift for room-to-room patient transfers without any more aid other than the one life motor.
It is able to lift “up to 200 kg (440 lb) and can be easily attached to or removed from the ceiling rail to facilitate convenient transport between rooms with minimal effort and no tools required.”
The Hillrom patient lift makes it easier to transfer patients between rooms, even in a sitting position, without having to use multiple transfer straps.
It is part of a system that has an overhead lift motor, the S65 rail carriage hook, and a Q-link strap that is used to secure the patient to the device.
What A Class I Recall Is And Why The Hillrom Multirall Patient Lift Recall Categorized As Such
According to the FDA, a Class I recall involves “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Class I recalls are the most urgent and serious types of recalls and are usually reserved for the most severe product defects.
Because of the gravity and seriousness of the events in a Class I recall, the FDA oversees the entire recall process and ascertains that the company or manufacturer will take proper and adequate measures in ensuring that the public is safe and protected.
The Hillrom patient lift recall warned the public that the lift’s Q-link strap lock does not properly attach or fasten to the S65 carriage hooks on the lift’s frame.
If this happens, the motor and/or the patient can fall from elevated heights unexpectedly.
This can cause adverse events such as severe, life-threatening injuries or death.
Because of this serious safety risk, the FDA has categorized this as a Class I recall and has urged Hillrom to take all measures to ensure the safety of healthcare providers, patients, and bystanders using the device.
What Hillrom is Doing About The Recall
Hillrom sent an Urgent Medical Device Correction letter on December 18, 2020, to all the affected facilities with the lift system to warn them about the danger.
The health care providers were instructed to inspect the multirall installations that they have in their facilities and determine if they are a category A, B, or C.
They were then instructed to fill out the response form that came with the letter and return it to Hillrom or to a distributor within a month.
The instructions also included a prompt to share the notice with other organizations and maintain awareness to ensure effectiveness.
Once the response forms have been returned, the company pledged to replace the Q-Link strap with the Q-Link 2 strap through a distributor.
However, facilities have been allowed to use the recalled patient lift system in the interim while awaiting replacements.
Editor’s Note on Hillrom Multirall Patient Transfer Lift Recall:
This article is written about the recent Class 1 recall concerning Hillrom Multirall Patient Transfer Lifts.
What are your thoughts on this piece? Please send us a message by clicking the ‘Contact Us’ button below. We’d love to hear back from you!