On October 14, 2022, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of Gibeck Iso-Gard Filters. FDA defines a Class 1 recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” On November 3, 2022, Teleflex Incorporated, maker of multiple medical technologies, announced a worldwide recall of certain lots of its Gibeck Iso-Gard Filter products.
Teleflex sent its U.S customers an Urgent Medical Device Recall letter on August 26, 2022, after receiving reports of the filter splitting or detaching. As of October 6, 2022, Teleflex has noted 38 complaints, including four injuries.
The Gibeck Iso-Gard Filter is a bacterial and viral filter. It is used in operating environments and intensive care units to connect and protect respiratory equipment from airborne contaminants.
If a filter splits or detaches during use, the device may fail to function efficiently. Risks include leakage and insufficient air supply to the patient, potentially causing desaturation.
The recall impacts 60,500 devices in the U.S. The specific products recalled so far, by Product Code and Commercial Name, are as follows:
- 19012 – Iso-Gard® Filter S with Expandi-Flex/Elbow
- 19012T – Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap
- 191667-000100 – Filter + Catheter Mount
- 19211; 19212 – Iso-Gard® Filter S
- 19261; 19272 – Iso-Gard® Filter S with Expandi-Flex
- 19261T; 19262T; 19272T – Iso-Gard® Filter S with Expandi-Flex, Tethered Cap
- 19211T; 19212T – Iso-Gard® Filter S, Tethered Cap
These lots were manufactured between December 17, 2019 and March 26, 2022 and distributed between September 1, 2020 to July 5, 2022. Teleflex is investigating an expansion of the recall.
Teleflex, headquartered in Wayne, PA, designs, develops, manufactures and distributes a variety of specialty medical devices, primarily for single use, primarily in bloodstream/vascular and surgical areas, by hospitals and healthcare providers. Founded in 1943, the business has expanded through numerous acquisitions and arrived at a focus on healthcare products after selling off businesses including car pedals and fiber-optics.
Current products include circuits, masks and bags, endotracheal tubes, pain pumps, supraglottic airways, catheters, adaptors and connectors. Teleflex brands include Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck. Teleflex previously recalled endotracheal tubes in 2019 over injury concerns.
Teleflex products are also sold by original equipment manufacturers (OEM). U.S. sales account for about 60% of the company’s revenues. Teleflex competitors include Integra LifeSciences, Boston Scientific, AngioDynamics and Halyard Health.
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