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U.S. Department of Health and Human Services

Class 2 Device Recall PowerLoc MAX Safety Winged Infusion Set

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  Class 2 Device Recall PowerLoc MAX Safety Winged Infusion Set see related information
Date Initiated by Firm March 13, 2015
Date Posted April 30, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
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