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TeleFlex Gibeck IsoGard Filter Recall & Other Supplier News

Here’s what was new in the world of medical device suppliers during the week of November 13.

On Nov. 3, Teleflex Incorporated announced a worldwide recall of affected lots of specific Gibeck IsoGard Filter products. The Gibeck IsoGard Filter is a bacterial and viral filter intended for connection to respiratory equipment in intensive care units and operating rooms to protect equipment from potential airborne contaminants.

The specific products involved in the recall include:

  • 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

The recall referenced multiple reports indicating that the filter split or detached during use. If the filter does this, its functionality and efficiency may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation. The company requests that users immediately check their inventory within the scope of the recall, quarantine affected product, cease use and distribution, and follow further instructions outlined in the recall letter.

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