Class 2 Device Recall

• Date Initiated by Firm: December 03, 2004
• Date Posted: June 17, 2005
• Recall Status: Terminated on April 19, 2012
• Recall Number: Z-0898-05
• Recall Event ID: 31878
• Product Classification: Needle, Fistula - Product Code FIE
• Product: Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6
• Code Information: All codes.
• Recalling Firm/ Manufacturer: HK Surgical Inc; 30280 Rancho Viejo Rd; San Juan Capistrano CA 92675-1561
• For Additional Information Contact: 949-369-0101
• Manufacturer Reason for Recall: Risk of hubs becoming disconnected from the cannula.
• FDA Determined Cause: Other
• Action: Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
• Quantity in Commerce: To be determined
• Distribution: Nationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.
• 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.