FDAFDA · Food and drugs·Recall number Z-0114-2016
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.
Published October 14, 2015 · Recall initiated: September 17, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Craniomaxillofacial Division
- Distributor
- Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
- Lot
- Part Number: 29-10911 Disposable Paper Filter for Sterilization Container, 30x29cm, new type (P/100); 29-10912 Disposable Paper Filter for Sterilization Container, 60x 29cm, old type (P/100), obsolete (Part not distributed in the US); 29-10913 Dispoable Paper Filter for Sterilization Container, 60x29cm new type (P/100) (Part not distributed in the US); 29-10915 Disposable Paper Filter, 4-holes, for Coiner (Part not distributed in the US)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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