Recall Z-0986-2017 ยท FPA Set, Administration, Intravascular
Bard Access Systems
SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
| Date | Jan 10, 2017 (initiated Dec 19, 2016) |
| Status | Terminated |
| Reason | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label. |
| Root cause | Mixed-up of materials/components |
| Action | Bard sent an Urgent Notification letter dated December 16, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify and return affected product. For questions call 1-800-290-1689. |
| Quantity | 8000 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040527 | LOW PROFILE LUTHER SAFETY HUBER Luther Needlesafe Products, Inc., Mar 26, 2004 |