Class 2 Device Recall Two Lead TUR Irrigation Set

• Date Initiated by Firm: May 15, 2013
• Date Posted: July 10, 2013
• Recall Status: Terminated on June 16, 2015
• Recall Number: Z-1683-2013
• Recall Event ID: 65183
• 510(K)Number: K960787
• Product Classification: System, irrigation, urological - Product Code LJH
• Product: Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
• Code Information: R06K01067 R06K01075 R06K01083 R07B02013 R07C14065 R07C22035 R07D19088 R07E07015 R07E20935 R07E29050 R07F02063 R07F05025 R07I22065 R07J01019 R07J28012 R07L05073 R08A14027 R08A28019 R08B04026 R08B05031 R08C18040 R08C24022 R08D12066 R08D15085 R08F28075 R08G19122 R08G21029 R08G21037 R08H21019 R08H27065 R08I20076 R08J10175 R08K04010 R08L05205 R09A17060 R09A28109 R09B16086 R09C16100 R09C30119 R09D14012 R09E19026 R09E25122 R09F10148 R09F16087 R09G14072 R09G27025 R09H27080 R09I28094 R09J13103 R09K11154 R09K30014 R09L09032 R09L16227 R10A08264 R10A19188 R10A21630 R10B13122 R10B16158 R10C10118 R10C13096 R10C24044 R10C27179 R10D05041 R10D26047 R10E11087 R10F05152 R10F19054 R10G27014 R10H17211 R10H31212 R10I01106 R10I07129 R10I27036 R10J19024 R10J19149 R10J23067 R10K02226 R10K13066 R10K25029 R10L04071 R10L23048 R11A11010 R11A15078 R11A31224 R11B07172 R11C01223 R11C15157 R11C22294 R11D04167 R11D16062 R11E12159 R11E21077 R11F24103 R11G18020 R11G18103 R11G19077 R11J24189 R11K22140 R11L22114 R12A04113 R12A11134 R12A23113 R12A31124 R12B15117 R12B27070 R12C08144 R12E17116 R12E18056 R12F07057 R12F09087 R12F11067
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
• FDA Determined Cause: Packaging
• Action: Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com
• Quantity in Commerce: 530,488 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 = LJH