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SPS Sterilization, Inc recalls Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75C
Recalled September 19, 2018 · FDA recall Z-3035-2018 · SPS Sterilization
Hazard
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. · FDA Class II
Units
2 units total
Sold at
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Description
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Product
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Manufacturer(s)
SPS Sterilization, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →