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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

Product Description Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Recall Number Z-1800-2012
Classification Class II
Code Info Product Code VIH-3333 -- lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, 97-040-9D, and 10-010-9D.
Product Distributed Qty
Reason For Recall Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

Event Detail

Event Id 61945
Product Type Devices
Status Ongoing
Recalling Firm Vygon Corporation
City Montgomeryville
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.