Z-0245-2023Class II

Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450...

Name: Z-0245-2023 Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450...
Creator: Tollos
Published: 2022-10-24
License: https://open.fda.gov/license/

Tollos / initiated 2022-10-24 / Open, Classified / root cause: manufacturing process

FDA source

Tollos began a recall of Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle... on 2022-10-24. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0245-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-24
Posted: 2022-11-17
Recalling firm: Tollos
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
Product code: FNG Lift, Patient, Ac-Powered
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).
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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].
Quantity in commerce: 1273 US; 70 OUS
Distribution: Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
Product codes and lots: UDI-DI 00817956021 (not yet uploaded to GUDID)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0245-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0245-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-17

Product code FNG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)