FDAFDA · Food and drugs·Recall number Z-1027-2013
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Published April 10, 2013 · Recall initiated: March 22, 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
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- US Nationwide Distribution
- Lot
- Codes: 10217 10201-002 10201 10202-001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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