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Open, Classified

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

FDA Recall Z-0245-2023 · Posted 2022-11-17

Recalling FirmTollos
Recall StatusOpen, Classified
Product CodeFNG
Date Initiated2022-10-24
Product Quantity1273 US; 70 OUS

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).

Firm Action

On October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. The firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed. Access complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins. Tollos can be contacted by e-mail at [email protected].

Root Cause

Equipment maintenance

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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