Class 2 Device Recall PowerLoc MAX Safety Winged Infusion Set

• Date Initiated by Firm: March 13, 2015
• Date Posted: April 30, 2015
• Recall Status: Terminated on June 24, 2015
• Recall Number: Z-1560-2015
• Recall Event ID: 70834
• 510(K)Number: K073050
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 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 for power injection.
• Code Information: Lot D430107
• Recalling Firm/ Manufacturer: Bard Access Systems; 605 North 5600 West; Salt Lake City UT 84116-3738
• For Additional Information Contact: Brenda Shelkey; 801-522-5974
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 700 units
• Distribution: US Distribution to states of: GA and MN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA