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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 Recall
Baxa Vial Adapter, 14mm Luer Lock
see related information
Date Posted September 06, 2013
Recall Status1 Open
Recall Number Z-2165-2013
Recall Event ID 66082
Premarket Notification
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, Colorado 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = BAXA CORP., SUB. OF COOK GROUP, INC.
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