Teleflex Inc., a provider of medical technologies for critical care and surgery, has expanded the recall of various Gibeck Iso-Gard Filter products worldwide, the U.S. Food and Drug Administration said.
The Gibeck Iso-Gard Filter, a bacterial and viral filter, is intended for connection to respiratory equipment in intensive care units and operating theatres. The filters are used to protect the equipment from potential airborne contaminants.
The agency noted that if the filter splits or detaches during use, the functionality and efficiency of the device may be compromised. This could potentially result in a leakage and insufficient air supply to the patient with potential desaturation.
Teleflex initiated th recall in late August after receiving reports indicating that the device split or detached during use. Teleflex is currently issuing an expansion to this recall to include additional lots.
As of October 6, a total of 38 complaints reporting the filter splitting or detaching have been received for the recalled products. Of these 38 complaints, 4 complaints reported injuries, including patient desaturation. However, no deaths or long-term patient injuries have been reported at this time.
The products involved in the recall include Iso-Gard Filter S with Expandi-Flex/Elbow; Iso-Gard Filter S with Expandi-Flex/Elbow, Tethered Cap; Filter + Catheter Mount; Iso-Gard Filter S; and Iso-Gard Filter S with Expandi-Flex, among others with various product codes.
The products were manufactured between December 17, 2019 and March 26, 2022.
The recall is being classified by the FDA as a Class I recall, which says "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."
Customers with the recalled product are urged to discontinue use, and return all affected product to Teleflex.
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