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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter

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  Class 2 Device Recall Baxter see related information
Date Initiated by Firm December 29, 2014
Date Posted February 27, 2015
Recall Status1 Terminated 3 on August 08, 2016
Recall Number Z-1227-2015
Recall Event ID 70128
Product Classification Dispenser, liquid medication - Product Code KYX
Product Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.
Code Information All DiscPac products are affected within expiry up to October 2017
Recalling Firm/
Manufacturer		 Baxter Corporation Englewood
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
FDA Determined
Cause 2		 Labeling Change Control
Action Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1.Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. Returning the customer reply form promptly will prevent you from receiving repeat notices. 2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. Action to be taken if you are an end-user and purchased product from a distributor or reseller: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter. Action to be taken if you are a distributor: If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.
Quantity in Commerce 1,404,230
Distribution Nationwide Distribution
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.
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