Gibeck Iso-Gard

2022: Equipment recall due to defective virus devices

In early November 2022, the US Department of Health began recalling some bacterial and viral filters. Gibeck Iso-Gard is a first-class recall from Teleflex.

Teleflex recalls several types of Iso-Gard Filter S filters after receiving reports that the filter may split or disconnect from respiratory systems. Filters are used as bacterial filters of respiratory circuits that connect to breathing equipment or respiratory systems in intensive care units and operating rooms. They protect equipment and patients from potential air pollutants.

Gibeck Iso-Gard

If the Iso-Gard Filter S is broken down or disconnected during use, it may not work properly and cause the patient to receive insufficient air and the patient's blood oxygen level may drop below a safe level. There is also a risk of cross-contamination.

The recall notice FDA says the use of these devices can lead to serious injury or death. At the beginning of November 2022, there were 36 complaints and four reports of injuries related to these devices, including desaturation. There were no reports of deaths or long-term injuries.

The recall applies to 60 thousand devices manufactured between December 17, 2019 and March 26, 2022, which were distributed between September 1, 2020 and July 5, 2022. Patients receiving care with respiratory systems using Iso-Gard Filter S and healthcare providers providing care for patients with respiratory systems using the device are at increased risk.

Specific batches that fell under the recall can be found in the FDA notice. The manufacturer recommends that medical institutions immediately check the inventory for products that fall under recall, stop using and distributing affected projects, and quarantine these devices. Distributors must also issue a recall notice to all customers who receive the product and ask each customer to complete a confirmation form and return the product to the distributor.^[1]

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