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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 Recall
Huber Plus NonCoring Needle Safety Infusion Set
see related information
Date Posted February 26, 2010
Recall Status1 Terminated on May 14, 2010
Recall Number Z-0862-2010
Recall Event ID 53341
Premarket Notification
510(K) Number
K993848 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, 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 Number: RETJ0656.
Recalling Firm/
Manufacturer
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 775 units
Distribution Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MILLENNIUM MEDICAL DISTRIBUTION, INC.
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