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Class 2 Device Recall |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 03, 2004 |
Date Posted |
June 17, 2005 |
Recall Status1 |
Terminated 3 on April 19, 2012 |
Recall Number |
Z-0900-05 |
Recall Event ID |
31878 |
Product Classification |
Needle, Fistula - Product Code FIE
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Product |
Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15. |
Code Information |
All Codes |
Recalling Firm/ Manufacturer |
HK Surgical Inc 30280 Rancho Viejo Rd San Juan Capistrano CA 92675-1561
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For Additional Information Contact |
949-369-0101
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Manufacturer Reason for Recall |
Risk of hubs becoming disconnected from the cannula.
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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
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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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