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U.S. Department of Health and Human Services

Class 2 Device Recall Vented Spike Adapter

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 Class 2 Recall
Vented Spike Adapter
see related information
Date Posted October 30, 2013
Recall Status1 Open
Recall Number Z-0109-2014
Recall Event ID 66222
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
Code Information R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The firm, Baxter, sent an "Urgent Product Recall" letter dated September 10, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from your facility; If you distributed the products to other facilities or departments, forward them a copy of the letter; complete and return the attached Customer Reply Form via fax to 1-224-270-5457 or scan and email to fca@baxter.com; and contact Baxter Healthcare Center for Service at 1-888-229-0001 between hours of 7:00 am and 6:00pm Central Time to return affected product and receiving credit. For additional information contact the Center for One Baxter at 1-800-422-9837, Monday thru Friday during the hours of 8:00am to 5:00pm Central Time.
Quantity in Commerce 49,344 units
Distribution Nationwide distribution.
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.
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