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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide distribution.