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Safety Report: Gibeck® and Iso-Gard® Bacterial and viral filters - recalled due to Bacterial and viral filters, USA

1 year ago •source fda.gov

Recall notice

United States

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.

The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.

Product Codes: 19012. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow

Product Codes: 19012T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap

Product Codes: 191667-000100. Commercial Name: Filter + Catheter Mount

Product Codes: 19211; 19212. Commercial Name: Iso-Gard® Filter S

Product Codes: 19261; 19272. Commercial Name: Iso-Gard® Filter S with Expandi-Flex

Product Codes: 19261T; 19262T; 19272T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex, Tethered Cap

Product Codes: 19211T; 19212T. Commercial Name: Iso-Gard® Filter S, Tethered Cap

Note: This recall is for specific lots of the above-referenced product codes.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Teleflex Incorporated
Brand name: Gibeck® and Iso-Gard®
Product recalled: Bacterial and viral filters
Reason of the recall: Bacterial and viral filters
FDA Recall date: November 04, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teleflex-announces-worldwide-recall-gibeckr-iso-gardr-filter

#medicaldevices #recall #us

321

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