FDA recall Z-0245-2023

Tollos · Class II · device

Product

Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000

Reason for recall

Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).

Distribution

Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.

Key facts

Status: Ongoing
Initiation date: 2022-10-24
Report date: 2022-11-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Owings Mills, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2023