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U.S. Department of Health and Human Services

Class 2 Device Recall Huber Plus NonCoring Needle Safety Infusion Set

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  Class 2 Device Recall Huber Plus NonCoring Needle Safety Infusion Set see related information
Date Initiated by Firm January 14, 2010
Date Posted February 26, 2010
Recall Status1 Terminated 3 on May 14, 2010
Recall Number Z-0861-2010
Recall Event ID 53341
510(K)Number K993848  
Product Classification Set, administration, intravascular - Product Code FPA
Product Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116.

Safety IV administration set used to access surgically implanted vascular ports.
Code Information Lot Numbers: RETK0229, RETJ0655.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact
801-522-5000
Manufacturer Reason
for Recall		 After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
FDA Determined
Cause 2		 Component change control
Action Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.
Quantity in Commerce 4,975 units
Distribution Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
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 = FPA and Original Applicant = MILLENNIUM MEDICAL DISTRIBUTION, INC.
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