Recall Z-0245-2023— Tollos
Class II · Ongoing
Class II FDA medical device recall by Tollos, initiated 2022-10-24. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- Tollos
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-24
- Firm location
- Owings Mills, MD, United States
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.