Teleflex Incorporated, a surgical technology company, has expanded its recall of Gibeck Iso-Gard Filter products, according to a recent U.S. Food and Drug Administration announcement. Gibeck Iso-Gard Filters are viral and bacterial filters designed to connect respiratory equipment in operating rooms and intensive care units. Gibeck Iso-Gard Filters are supposed to protect the equipment and patient from […]
Teleflex Incorporated, a surgical technology company, has expanded its recall of Gibeck Iso-Gard Filter products, according to a recent U.S. Food and Drug Administration announcement. Gibeck Iso-Gard Filters are viral and bacterial filters designed to connect respiratory equipment in operating rooms and intensive care units. Gibeck Iso-Gard Filters are supposed to protect the equipment and patient from unsafe airborne contaminants.
The U.S. Food and Drug Administration reported that certain models split or detach during use leading to a dangerous leakage and insufficient air supply to the patient. A patient that experiences insufficient air supply can suffer brain damage or death.
Teleflex initiated the recall last August after the company received reports that certain Gibeck Iso-Gard Filters can split or detach during use. The medical technology company is now issuing an expansion to its previous recall. This new recall includes additional lots.
So far, Teleflex has been notified of at least 38 reports of the affected filters splitting or detaching. Four of these complaints reported injuries and desaturation incidents. The affected products, include:
The Iso-Gard Filters were made between December 17, 2019, and March 26, 2022. This is a Class I recall, according to the U.S. Food and Drug Administration. Class I recalls are the most serious type of recall because the recalled product has been linked with injuries and deaths. Customers who have the recalled filters in their inventory are urged to immediately stop using the filters and return the Iso-Gard filters to Teleflex.
If you or a loved one was harmed by a recalled Iso-Gard filter, contact our law firm for your free case review.
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