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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66222
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070 Class II Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 49,344 units Z-0109-2014