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Class 2 Device Recall 45cm Laparoscopic Instruments Sterilization tray |
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Date Initiated by Firm |
June 08, 2011 |
Date Posted |
June 22, 2011 |
Recall Status1 |
Terminated 3 on October 25, 2011 |
Recall Number |
Z-2612-2011 |
Recall Event ID |
59072 |
510(K)Number |
K960738
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Product Classification |
Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
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Product |
45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138
Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.
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Code Information |
Model number 250-015-704. All serial/lot numbers. |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138-1400
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For Additional Information Contact |
Michael Hillendoerfer 408-754-2664
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Manufacturer Reason for Recall |
During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Stryker Endoscopy sent a "URGENT: DEVICE CORRECTION" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers.
Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link:http://stryker.com/45cm tray. Additionally, customers were instructed to complete and return an attached "acknowledgement of receipt" form and fax to 408-754-8378 or scan and e-mail to trays@stryker.com.
Questions can be answered by calling 1-800-624-4422 or by e-mail at trays@stryker.com. |
Quantity in Commerce |
603 |
Distribution |
Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KCT and Original Applicant = ENGINEERED CUSTOM MFG., INC.
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