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.
FDA Recall Z-0861-2010 · Posted 2010-02-26
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Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeFPA
Date Initiated2010-01-14
Date Terminated2010-05-14
Product Quantity4,975 units
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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