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U.S. Department of Health and Human Services

Class 2 Device Recall Baxa Vial Adapter, 14mm Luer Lock

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  Class 2 Device Recall Baxa Vial Adapter, 14mm Luer Lock see related information
Date Initiated by Firm August 22, 2013
Date Posted September 06, 2013
Recall Status1 Terminated 3 on August 19, 2016
Recall Number Z-2165-2013
Recall Event ID 66082
510(K)Number K900585  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890.

Used as a needleless access device for reconstitution and drug transfer.
Code Information Lot or Serial No. 785518
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Kimberly Zizik
303-617-2242
Manufacturer Reason
for Recall		 Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
FDA Determined
Cause 2		 Labeling Change Control
Action An Urgent Product Recall notification was mailed to one customer via USPS First Class mail on 8/22/13. The one customer affected by this action was instructed to locate and remove the affected product from inventory and to return to Baxter for credit and/or replacement. Any customer returns received will be discarded per the Corporate Hold.
Quantity in Commerce 34 cases
Distribution Distributed to One Customer in NC.
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 = BAXA CORP., SUB. OF COOK GROUP, INC.
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