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Stryker Endoscopy recalls 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instrum
Recalled May 14, 2014 · FDA recall Z-1544-2014 · Stryker Endoscopy
Hazard
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing. · FDA Class II
Units
2591 trays
Sold at
Worldwide distribution
Description
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Product
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
Manufacturer(s)
Stryker Endoscopy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →