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Microtek Medical Inc. recalls C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod
Recalled August 28, 2024 · FDA recall Z-2639-2024 · Microtek Medical
Hazard
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. · FDA Class II
Units
10,366 cases (518,300 units)
Sold at
Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
Description
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Product
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Manufacturer(s)
Microtek Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →