FDA has designated Hillrom’s recall of its Liko Multirall 200 overhead lift as Class I, its most serious level.
Hillrom (NYSE:HRC) initiated the recall on Dec. 18, 2020. It involves 11,600 devices, which are used to move patients from room to room. The recalled devices have a risk of the Q-link strap locks not attaching to the S65 carriage hook as they should. When the strap lock does not attach, the motor or patient may fall, according to the FDA warning letter. Use of the Liko Multirall 200 lift could result in adverse events such as serious injury or death.
FDA said there have been 34 complaints about the device and 22 reports of serious injuries. Two deaths have been reported.
“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 in an email.
Hillrom said in its recall notice the company will contact customers to plan the replacement of the Q-Link strap with the Q-Link 2 strap once units have been identified and the response form is returned.
Devices affected by the recall were manufactured between December 2000 and October 2020. They were distributed between Dec. 17, 2000 and Oct. 1, 2020.
Liko 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 1000-1400mm (product number 3136229)