Class 2 Device Recall Baxter Solution Set for Epidural Use

• Date Initiated by Firm: May 31, 2011
• Date Posted: June 29, 2011
• Recall Status: Terminated on June 18, 2012
• Recall Number: Z-2708-2011
• Recall Event ID: 58913
• 510(K)Number: K925058
• Product Classification: set, administration, intravascular - Product Code FPA
• Product: Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554s; ; The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours.
• Code Information: product code 2C7554s, lot GR293209 *** The recall was expanded to include lots GR291559 and GR294928 ***
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
• FDA Determined Cause: Employee error
• Action: Baxter Healthcare sent Urgent Product Recall letters dated May 31, 2011, via UPS overnight delivery to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/31/11, and instructed to notify their customers and ministries of health of the recall. *** The recall was expanded to include two additional lots of product code 2C7554s on July 11, 2011 via letter of the same date. The recall strategy remains the same as that of May 31, 2011. ***
• Quantity in Commerce: 13,920 units
• Distribution: Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa.
• 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 = C.R. BARD, INC.