FDA-Device2015-10-14Class II
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Stryker Craniomaxillofacial Division
Hazard
Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
Sold states
Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Affected count
915 packs
Manufactured in
750 Trade Centre Way, Ste 200, Portage, MI, United States
Products
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2016Don't want to check this manually?
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