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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 Adaptersee related information
Date Initiated by FirmNovember 30, 2015
Create DateJanuary 07, 2016
Recall Status1 Terminated 3 on October 30, 2016
Recall NumberZ-0606-2016
Recall Event ID 72787
510(K)NumberK860272 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBaxter 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. .
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 ContactCenter 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
ActionBaxter 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 Commerce9600 units
DistributionUS Nationwide Distribution and the country of Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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