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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 Recall
Baxter Solution Set with DuoVent Spike
see related information
Date Posted August 03, 2011
Recall Status1 Terminated on June 18, 2012
Recall Number Z-2920-2011
Recall Event ID 59419
Premarket Notification
510(K) Number
K961225 
Product Classification Set, Administration, Intravascular - 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, Illinois 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
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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