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U.S. Department of Health and Human Services

Class 2 Device Recall I.V. Container

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  Class 2 Device Recall I.V. Container see related information
Date Initiated by Firm July 27, 2017
Date Posted January 11, 2018
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-0485-2018
Recall Event ID 78042
510(K)Number K964853  
Product Classification Container, i.V. - Product Code KPE
Product Empty IntraVia Container with Non-DEHP Fluid Path, 500mL

Containers are intended for use in the preparation and administration of drug admixtures.
Code Information Product Code 2J8003, Lot No. DR16J18096.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 A leak may allow for microbial contamination of the sterile fluid path.
FDA Determined
Cause 2		 Process control
Action US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.
Quantity in Commerce 29,088 units
Distribution Distribution in the US and 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 = KPE and Original Applicant = BAXTER HEALTHCARE CORP.
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