Recall Z-1544-2014— Stryker Endoscopy

Name: FDA recall Z-1544-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Class II · Terminated

Class II FDA medical device recall by Stryker Endoscopy, initiated 2014-04-16, terminated 2014-08-18. It names one FDA 510(k) clearance: K935237. 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.. Reason: Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing..

Recalling firm: Stryker Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Terminated: 2014-08-18
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K935237 — STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIESStryker Endoscopy·cleared 1994-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.