Class 2 Device Recall 12 Instrument Sterilization Tray

• Date Initiated by Firm: April 16, 2014
• Date Posted: May 02, 2014
• Recall Status: Terminated on August 18, 2014
• Recall Number: Z-1544-2014
• Recall Event ID: 68045
• 510(K)Number: K935237
• Product Classification: Electrosurgical, cutting & coagulation & - Product Code GEI
• 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.
• Code Information: Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1, 36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129, 43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476, 43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542, 41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1, 51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1, 37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1, 48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445, 42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843, 42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610, 43893-1-13, 39219, 43893-1-2, 43893-1-14.
• FEI Number: 2936485
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Michael Hilldoefer; 408-754-2664
• Manufacturer 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.
• FDA Determined Cause: Reprocessing Controls
• Action: Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to endorecall@stryker.com. For questions call 1-800-624-4422 option 3 or via email at endorecall@stryker.com.
• Quantity in Commerce: 2591 trays
• Distribution: Worldwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI