Class 2 Device Recall Bard Access

• Date Initiated by Firm: August 08, 2014
• Date Posted: March 13, 2015
• Recall Status: Terminated on August 05, 2015
• Recall Number: Z-1273-2015
• Recall Event ID: 70430
• 510(K)Number: K040527 K050600 K073050
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in ; ; The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
• Code Information: Lot Numbers: REXE0073, REXD0494, REYF0446, REXE0074, REXE0090, REYE1239, REXD1915, REXD2151, REXD2152, REYE1275, REYF0305, REXD2142, REYE1697, REXE0082, REYE1240, REYE0972, REXE0083, REXE0072, REXE0095, REYE1276, REXE0081, REYE1267, REYE1568, REXD1616, REXE0087, REYE1232, REYE1567, REXE0092, REXE0094, REYE1585, REXD1936, reye0216, REYE1707, REYE1270, REXE0075, REYF0303, reyd1639, REXE0084, REXE0088, REYE1566, REXD1918, REYE1266, REXE0091, REYE1694, REXD1930, REYE1231, REXD2153, REXD2154, REXE0076, REYE1693 Product codes: PA-0029, PA-0029YN, PA-0030, PA-0031, PA-0031YN, PA-0032, PA-0032YN, PA-0033, PA-0033YN, PA-0034, PA-0034YN, PA-0038, PA-0038YN, 2632010, 2632034, 2632210, 2632234, 2681910, 2682010, 2682034, 2682215, 2682234, 2131910, 2131975, 2132075, 2141910, 2142010, 2142075, 2142210, 2142275
• Recalling Firm/ Manufacturer: Bard Access Systems; 605 N 5600 W; Salt Lake City UT 84116-3738
• For Additional Information Contact: Ms. Shelly Gilbert; 801-595-0700
• Manufacturer Reason for Recall: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.
• Quantity in Commerce: 135,284 units
• Distribution: US Nationwide Distribution.
• 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 = LUTHER NEEDLESAFE PRODUCTS, INC.; 510(K)s with Product Code = FPA and Original Applicant = SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.; 510(K)s with Product Code = FPA and Original Applicant = SPECIALIZED HEALTH PRODUCTS, INTL.