The FDA this week said the Teleflex (NYSE:TFX) recall of some Gibeck Iso-Gard bacterial and viral filters is a Class I recall, the most serious kind.
Teleflex is recalling several types of the Iso-Gard Filter S after receiving reports that the filter may split or become detached from breathing systems.
Iso-Gard Filter S filters are used as breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in intensive care units and operating rooms. They protect the equipment and the patients from potential airborne contaminants.
If the filter splits or detaches during use, the filter may not work properly and could cause a patient to receive an insufficient supply of air, with patient oxygen levels potentially dropping below safe levels. There is also a risk of cross-contamination.
The FDA said in a recall notice that using these devices could result in serious injury or death. So far, there have been 36 complaints and four injury reports related to the devices, including desaturation. There have been no reports of deaths or long-term injuries.
The recall involves 60,500 devices manufactured between Dec. 17, 2019 and March 26, 2022, that were distributed between Sept. 1, 2020 and July 5, 2022. Patients who receive care from breathing systems that use the Iso-Gard Filter S and healthcare professionals providing care for patients with the breathing systems that use the device are more at risk.
Products affected in the recall include:
Specific lots in the recall can be found in the FDA notification.
Teleflex is recommending medical facilities immediately check inventory for products within the recall scope and to stop using and distributing affected projects and quarantine those devices. The company will issue credit notes after receiving returned affected products.
Distributors should also provide a recall notice to all customers who received the product and have each customer complete an acknowledgment form and return the product to the distributor.