The Recall Desk
HighFDA (Devices)·Z-0245-2023·Announced 2022-11-23

Infection Control Lifting Strap Recalled for Patient Safety Risk Due to Breakage

Tollos is recalling Infection Control (IC) Lifting Straps used with certain Cirrus and Pinnacle ceiling lifts because the straps can break during patient lifts, potentially causing patients or caregivers to be injured by falls.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with documented strap failures (4 incidents) creating risk of patient falls and serious injury to patients or caregivers. No injuries have been reported. Meets High severity threshold as a risk-of-harm product without reported injury.

Plain-English summary

Tollos is recalling Infection Control (IC) Lifting Straps used with Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000 ceiling lifts. The strap can break during patient lifting, potentially causing patients or caregivers to fall and be injured.

Two customers reported four incidents in which the IC lifting strap broke while lifting patients. When the strap fails, there is risk of the patient falling, which could result in injury to the patient or nearby caregivers.

The recalled lifting straps were distributed nationwide in the US, and to facilities in Canada and the United Arab Emirates.

Stop using the recalled IC lifting strap immediately. Contact Tollos to obtain a safe replacement. Do not attempt to continue using the lift system with a damaged or failing strap.

The recalled product

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
Manufacturer
Tollos
Category
Medical Device — Patient Lift Equipment
Hazard
  • strap-failure
  • fall-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI 00817956021 (not yet uploaded to GUDID)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category