RecallDepth

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

Company
Tollos
Recall Initiated
October 24, 2022
Posted
November 17, 2022
Recall Number
Z-0245-2023
Quantity
1273 US; 70 OUS
Firm Location
Owings Mills, MD

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.

Lot / Code Info

UDI-DI 00817956021 (not yet uploaded to GUDID)

Root Cause

Equipment maintenance

Action Taken

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 service@tollos.com.