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.
This recall has been terminated (originally issued February 26, 2010).
- Company
- Bard Access Systems
- Recall Initiated
- January 14, 2010
- Posted
- February 26, 2010
- Terminated
- May 14, 2010
- Recall Number
- Z-0862-2010
- Quantity
- 775 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
Lot / Code Info
Lot Number: RETJ0656.
Root Cause
Component change control
Action Taken
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.