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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System NonDHEP Extension Set

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  Class 2 Device Recall Baxter Interlink System NonDHEP Extension Set see related information
Date Initiated by Firm September 09, 2010
Date Posted October 27, 2010
Recall Status1 Terminated 3 on September 07, 2011
Recall Number Z-0151-2011
Recall Event ID 56718
510(K)Number K962581  
Product Classification Stopcock, i.V. Set - Product Code FPA
Product Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Injection Site, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N5602
For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information product 2N5602, lots UR171421, UR188847, UR216556, UR233510, UR239897, UR239962, UR240036, UR256172, UR262741, UR274365, UR288290, UR299370, UR320085, UR324343, UR08C11045, UR137315, UR143602, UR156497, UR164178, UR164798, U254078R, U256941R, U284562R, U332536R, U332643R, U468785R, U473728R, U480780R, U490003R, U493031R, U495069R, U497420R, U497826R, U497867R, U497941R, U510016R, U510115R, U530972R, U538090R, U546036R, U548107R, U560847R and U572503R 
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		 During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
FDA Determined
Cause 2		 Package design/selection
Action Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; 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 could 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.
Quantity in Commerce 60,400 sets
Distribution Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
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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