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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 03, 2004
Date PostedJune 17, 2005
Recall Status1 Terminated 3 on April 19, 2012
Recall NumberZ-0900-05
Recall Event ID 31878
Product Classification Needle, Fistula - Product Code FIE
ProductGold 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
For Additional Information Contact
949-369-0101
Manufacturer Reason
for Recall		Risk of hubs becoming disconnected from the cannula.
FDA Determined
Cause 2		Other
ActionRecall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
Quantity in CommerceTo be determined
DistributionNationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.
Total Product Life CycleTPLC 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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