| Class 2 Device Recall Pressure Monitoring sets | |
Date Initiated by Firm | January 30, 2013 |
Date Posted | April 18, 2013 |
Recall Status1 |
Terminated 3 on March 10, 2016 |
Recall Number | Z-1146-2013 |
Recall Event ID |
64229 |
510(K)Number | K896819 K925638 |
Product Classification |
Catheter, continuous flush - Product Code KRA
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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 CA 92614-5688
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KRA
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