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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64229
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Irvine
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI and country of: Europe.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples. 59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041, 59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771. Class II The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. 30,467 Z-1146-2013