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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Solution Set with DuoVent Spike

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  Class 2 Device Recall Baxter Solution Set with DuoVent Spike see related information
Date Initiated by Firm July 21, 2011
Date Posted August 03, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall Number Z-2920-2011
Recall Event ID 59419
510(K)Number K961225  
Product Classification Intravascular Administration Set - Product Code FPA
Product Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL.
Baxter Healthcare Corporation.

A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
Code Information Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.
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 Solution Sets are 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 2		 Employee error
Action Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in Commerce 4,752 units
Distribution (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
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.
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