Class 2 Device Recall Baxter BURETROL Solution Set

• Date Initiated by Firm: July 14, 2014
• Date Posted: September 09, 2014
• Recall Status: Terminated on March 15, 2016
• Recall Number: Z-2615-2014
• Recall Event ID: 68843
• 510(K)Number: K123874
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: ***Baxter***Non-DEHP***BURETROL Solution Set; 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve; 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***
• Code Information: 2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: 224-948-4770
• Manufacturer Reason for Recall: Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Action to be taken if product was purchased directly from Baxter: Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
• Quantity in Commerce: 11184
• Distribution: 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 = BAXTER HEALTHCARE CORP.