Recall Z-1560-2015 ยท FPA Set, Administration, Intravascular
Bard Access Systems
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated
| Date | Apr 30, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Bard, sent an "URGENT: Notification-Potential Incorrect Infusion IFU Label for PowerLoc MAX Safety Winged Infusion Set (SWIS)" letter dated March 25, 2015 to its customers. The letter described the product, problem and actions taken. The firm has corrected the cause of the issue and all future lots will be manufactured with the correct maximum flow rate of 2mL/second. Customers may return for a replacement or keep items. Please direct any return requests and questions to our coordinator at 801-522-5640. |
| Quantity | 700 units |
| Distribution | US Distribution to states of: GA and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073050 | SAFESTEP MAX POWER-INJECTABLE INFUSION SET Specialized Health Products International, Inc., Jan 25, 2008 |