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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System, YType Solution Set, 78 (2.0m), 2 Injection Sites, Male Luer Lock Adapter

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  Class 2 Device Recall Baxter Interlink System, YType Solution Set, 78 (2.0m), 2 Injection Sites, Male Luer Lock Adapter see related information
Date Initiated by Firm November 30, 2015
Create Date January 07, 2016
Recall Status1 Terminated 3 on October 30, 2016
Recall Number Z-0606-2016
Recall Event ID 72787
510(K)Number K860272  
Product Classification Set, administration, intravascular - Product Code FPA
Product Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s,

Product Usage:
C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device.
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Code Information Lot Numbers: GR324012, GR325322, GR326769, and GF328518
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
224-948-2000
Manufacturer Reason
for Recall		 Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.
Quantity in Commerce 9600 units
Distribution US Nationwide Distribution and the country of 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 = TRAVENOL LABORATORIES, S.A.
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