Class 2 Device Recall StrykeFlow

• Date Initiated by Firm: November 18, 2005
• Date Posted: December 14, 2005
• Recall Status: Terminated on November 02, 2006
• Recall Number: Z-0279-06
• Recall Event ID: 34112
• 510(K)Number: K042454
• Product Classification: Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
• Product: StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
• Code Information: Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
• FEI Number: 2936485
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138
• Manufacturer Reason for Recall: Devices for which sterility may be compromised as evidenced by a crack in the package.
• FDA Determined Cause: Other
• Action: On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
• Quantity in Commerce: 48405 boxes, 6 units per box
• Distribution: The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
• 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 = GCX