Recall Z-0861-2010 ยท FPA Set, Administration, Intravascular
Bard Access Systems
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.
| Date | Feb 26, 2010 (initiated Jan 14, 2010) |
| Status | Terminated |
| Reason | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. |
| Root cause | 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 | 4,975 units |
| Distribution | Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993848 | MILLENNIUM HUBER PLUS SAFETY INFUSION SET Millennium Medical Distribution, Inc., Jan 27, 2000 |