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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System Large Bore 4Way Stopcock

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 Class 2 Recall
Baxter Interlink System Large Bore 4Way Stopcock
see related information
Date Posted June 22, 2011
Recall Status1 Terminated on June 18, 2012
Recall Number Z-2623-2011
Recall Event ID 58834
Premarket Notification
510(K) Number
K962581 
Product Classification Stopcock, I.V. Set - Product Code FMG
Product Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information product code 2N5601, lot number UR08C31068
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
There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Baxter Urgent Product Recall letters dated May 17, 2011 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that potential pinholes and tears in the individual packaging could compromise the sterility of the stopcock. The accounts were requested 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 5/17/11, and instructed to notify their customers and ministries of health of the recall.
Quantity in Commerce 4,800 units
Distribution California and internationally to Japan and Australia
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 = FMG and Original Applicant = BAXTER HEALTHCARE CORP.
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