Z-0245-2023 Class II Ongoing
FDA device recall Z-0245-2023 was initiated by Tollos on October 24, 2022 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 1273 US; 70 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- October 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1273 US; 70 OUS
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).
Distribution Pattern
Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
Code Information
UDI-DI 00817956021 (not yet uploaded to GUDID)