Table of contents
- Latest Hillrom Liko Multirall 200 Lift Recall Updates
- September 26, 2023: FDA Terminates the Recall
- February 22, 2021: FDA Publishes the Class I Notice
- January 29, 2021: FDA Posts the Recall Record
- December 18, 2020: Hillrom Starts the Recall
- Which Hillrom Liko Multirall 200 Lifts Are Affected?
- Why Were the Hillrom Liko Multirall 200 Lifts Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Legal Options
- Frequently Asked Questions
- What Are Categories A, B and C in the Hillrom Recall Notice?
- What Were the Hours for Hillrom Technical Support?
- Where Did the Notice Say to Send the Hillrom Response Form?
- Where Were the Affected Hillrom Lifts Distributed?
- How Do I Report a Problem with the Liko Multirall 200?
Hillrom recalled the Liko Multirall 200 overhead lift, used in nursing homes and hospitals. The Q-link strap lock may not attach to the S65 carriage hook. If it does not, the lift motor or the patient may fall.
The FDA calls it a Class I recall, the most serious type. Hillrom began the correction in late 2020. The FDA terminated it on September 26, 2023.
The notice warns of serious injury and death. The lift moves patients from room to room in nursing homes, rehabilitation facilities and hospitals.
Latest Hillrom Liko Multirall 200 Lift Recall Updates
September 26, 2023: FDA Terminates the Recall
On September 26, 2023, the FDA terminated the Hillrom recall of the Liko Multirall 200 overhead lift. The FDA recall record lists it as Z-0925-2021 under event 87053 [1].
February 22, 2021: FDA Publishes the Class I Notice
On February 22, 2021, the FDA published the notice on the recall [2]. The FDA said it had identified the action as a Class I recall, the most serious type of recall.
The notice said use of the affected product may cause adverse events such as serious injury and death. MedTech Dive covered the Class I recall [3].
January 29, 2021: FDA Posts the Recall Record
On January 29, 2021, the FDA posted the recall record Z-0925-2021 for the Liko Multirall 200. It names the Urgent Medical Device Correction as the action and gives Device Design as the cause the FDA determined.
December 18, 2020: Hillrom Starts the Recall
On December 18, 2020, Hillrom started the recall. It sent an Urgent Medical Device Correction letter to distributors and end users.
The FDA record gives this date as the date the firm initiated the recall. The FDA later classified the action as Class I.
Which Hillrom Liko Multirall 200 Lifts Are Affected?
The recall covers the Liko Multirall 200 lift and seven accessories. The product numbers are:
- Liko Multirall 200 (3130001)
- Universal SlingBar 450 R2R (3156095)
- Universal SlingBar 350 R2R (3156094)
- Carriage D45 with Double Hook (3136100)
- Extension belt 300-400 mm (3136226)
- Extension belt 400-600 mm (3136227)
- Extension belt 600-1000 mm (3136228)
- Extension belt 1000-1400 mm (3136229)
Hillrom made the lifts from December 2000 to October 2020 and distributed them from December 17, 2000 to October 1, 2020.
Health care providers, patients and bystanders around the device may be affected. Common places of use are nursing homes, rehabilitation facilities and hospitals.
Why Were the Hillrom Liko Multirall 200 Lifts Recalled?
Hillrom recalled the lifts because of customer reports that the strap lock does not attach to the S65 carriage hook as it should.
The manufacturer’s stated reason is that the user had not fully engaged the Q-link strap lock in the S65 rail carriage hook. That can leave the lift detached from the rail system.
The FDA notice describes serious injury and death as possible risks. It makes no finding about the cause of each report.
Reported Incidents, Injuries, or Illnesses
The FDA notice reports 34 complaints about this device issue. It also reports 22 reports of serious injuries. Two deaths have been reported.
The notice does not say how many of these reports came from a fall caused by the strap lock. Reports are not proof that the lift caused every incident.
MassDevice reported that the recall involves 11,600 devices [4]. The FDA record counts 10,470 units in commerce plus 154 in an expanded recall.
What Should Consumers Do?
The February 2021 FDA notice told providers and users of the Liko Multirall 200 to take these steps before the FDA terminated the recall in 2023:
- Find the serial number on the product label attached to the lift.
- Inspect each Multirall installation and sort it into one of the categories the notice describes.
- Fill out the response form and return it to Hillrom or a Hillrom distributor.
- Share the notice with other organizations as appropriate.
- Expect Hillrom or a distributor to plan the swap of the Q-link strap for the Q-Link 2 strap once your units are identified.
- Call Hillrom Technical Support at (812) 934-7777 with questions about the recall.
Legal Options
Someone hurt in a fall from a recalled lift may ask a lawyer to review their facts. No lawsuit, class action or MDL names the Liko Multirall 200.
A recall by itself does not establish liability, and it does not automatically make any injured person eligible for a claim.
Frequently Asked Questions
What Are Categories A, B and C in the Hillrom Recall Notice?
Categories A, B and C in the Hillrom recall notice describe how a lift is set up. Category A is used with a Universal SlingBar 350 R2R, 450 R2R or Carriage D45 with Double Hook. B is combined with an extension belt, and C has neither.
What Were the Hours for Hillrom Technical Support?
The FDA recall notice listed Hillrom Technical Support hours of 8 am to 7 pm ET Monday through Thursday and 8 am to 6 pm ET on Friday. The notice asked callers with recall questions to use that support line.
Where Did the Notice Say to Send the Hillrom Response Form?
The recall notice said to send the Hillrom response form to Hillrom by email at MOD1322@hillrom.com. A Hillrom distributor could also take the completed form, according to the notice for the Liko Multirall 200.
Where Were the Affected Hillrom Lifts Distributed?
The affected Hillrom lifts were distributed nationwide in the US and in 24 other countries, according to the FDA recall record: AT, AU, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IS, IT, JP, LV, NL, NO, NZ, SE and SK.
How Do I Report a Problem with the Liko Multirall 200?
You can report a problem with the Liko Multirall 200 to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care professionals and consumers may use an online form, regular mail or FAX.