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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 Recall
Baxter, VIALMATE Adaptor
see related information
Date Posted November 26, 2013
Recall Status1 Terminated on July 22, 2014
Recall Number Z-0392-2014
Recall Event ID 66389
Premarket Notification
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, Illinois 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = BAXTER HEALTHCARE CORP.
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