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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter NonDEHP MicroVolume Extension Set

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  Class 2 Device Recall Baxter NonDEHP MicroVolume Extension Set see related information
Date Initiated by Firm December 14, 2012
Create Date August 29, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-2687-2016
Recall Event ID 63898
510(K)Number K042936  
Product Classification Set, administration, intravascular - Product Code FPA
Product Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case;
For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information product code 2N3345, lot number UR12E03108
Recalling Firm/
Baxter Healthcare Corp.
Route 120 And Wilson Rd
Round Lake IL 60073-9799
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Baxter sent an Urgent Product Recall notification letter dated December 14, 2012, to all affected customers. Baxter instructed customers to locate and remove all affected product from their facility. Customers were instructed to contact Baxter Healthcare Center for Service to arrange for return of product and credit and to complete the attached Customer Reply Form and return it to Baxter or scanned email. Customers with questions should call 1-888-229-0001. For questions regarding this recall call 800-422-9837.
Quantity in Commerce 15,257 units
Distribution Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
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.