FDAFDA · Food and drugs·Recall number Z-0402-2014
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Published December 4, 2013 · Recall initiated: November 11, 2013
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
Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- Nationwide Distribution
- Lot
- Please refer to consignee list
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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