FDA (Devices) recall action 94780
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
The agency’s own wording, quoted from the enforcement report.
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.