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U.S. Department of Health and Human Services

Class 2 Device Recall Pressure Monitoring sets

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 Class 2 Recall
Pressure Monitoring sets
see related information
Date Posted April 18, 2013
Recall Status1 Open
Recall Number Z-1146-2013
Recall Event ID 64229
Premarket Notification
510(K) Numbers
K896819  K925638 
Product Classification Catheter, Continuous Flush - Product Code KRA
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine, California 92614-5688
For Additional Information Contact Edwin Ramos
787-229-5699
Manufacturer Reason
for Recall
The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action The firm initiated a recall in Europe via customer letters starting January 30, 2013 to notify the recall of model number T001691A lot number 59326333. The recall was expanded and a worldwide recall via customer letters was initiated on February 11, 2013. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 30,467
Distribution 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 Europe.
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.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BAXTER HEALTHCARE CORP.
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