Class 2 Device Recall NonDEHP Catheter Extension Set

• Date Initiated by Firm: March 28, 2013
• Date Posted: May 07, 2013
• Recall Status: Terminated on July 31, 2017
• Recall Number: Z-1269-2013
• Recall Event ID: 64696
• 510(K)Number: K925126
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
• Code Information: A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: 224-948-2000
• Manufacturer Reason for Recall: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
• FDA Determined Cause: Packaging process control
• Action: Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
• Quantity in Commerce: A) Product Code 2N3371: 228,200 units
• Distribution: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
• 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