Reported May 14, 2014 · Terminated
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical…
Stryker Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- 12-Instrument Sterilization Tray
- Product UsageThe 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
- Lot codes and dates
- Model number0242000012
- Lot/serial numbers
84 of 84 codes
021464-239824-1-14014643893-1-42741942901-1-135728-2-148639-1-8021464-340288-1-14302043893-1-62770143104-1-136175-1-148956-1-12302740629-3-14362243893-1-72912943270-1-136421-1-148956-1-1A2339840721-1-15047643893-1-82967043523-1-136424-1-151304-1-12354241231-4-15499043893-1-93025043523-1-1A37251-1-151304-1-1A2384641478-1-17J148639-1-23091943674-1-137392-1-152123-1-12407341745-1-112348639-1-3321843893-1-137794-1-152956-1-12451142086-1-128646-1-1
- Amount recalled
- 2591 trays
Why it was recalled
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
This product could cause temporary or reversible health problems — stop using it.
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