Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600,
Summary
The FDA issued a Class II for Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle by Tollos. Reason: 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.
Details
Source
Device Recall
External ID
Z-0245-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI 00817956021 (not yet uploaded to GUDID)
Quantity Affected: 1273 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).
Distribution
Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-24
Company
Owings Mills, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tollos) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tollos have FDA actions?
This is the only FDA action we have on record for Tollos in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0245-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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