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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 03, 2004
Date Posted June 17, 2005
Recall Status1 Terminated 3 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 2		 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.
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