FDA Recall Terminated

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.

Recall: Z-0862-2010 · Initiated January 14, 2010

Recall

Recall Number
Z-0862-2010
Event Number
53341
Firm
Bard Access Systems
FEI Number
3006260740
Product Code
FPA
Status
Terminated
Root Cause
Component change control
Initiated
January 14, 2010
Posted
February 26, 2010
Terminated
May 14, 2010
Address
605 North 5600, West Salt Lake City, UT, 84116-3738

Description

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.

Reason

After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.

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.

Distribution

Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.

Quantity

775 units