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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter, VIALMATE Adaptor

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  Class 2 Device Recall Baxter, VIALMATE Adaptor see related information
Date Initiated by Firm September 25, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on July 22, 2014
Recall Number Z-0392-2014
Recall Event ID 66389
510(K)Number K973654  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA

The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
Code Information Lot Number GR13G23028
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
224-948-4770
Manufacturer Reason
for Recall		 Incomplete foil seal on one lot of sterile product.
FDA Determined
Cause 2		 Packaging process control
Action Baxter Healthcare sent an Urgent Product Recall letter dated September 25, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected product from their facility, contact Baxter's Center for Service at 1-888-229-0001 to arrange for return and credit. Complete the attached Customer Reply Form and return it to Baxter by fax or email. Customers with questions were instructed to call 1-800-422-9837. For questions regarding this recall call 224-948-4770.
Quantity in Commerce 38,400 units
Distribution Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
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 = LHI and Original Applicant = BAXTER HEALTHCARE CORP.
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