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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Lifesciences Crimpers

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 Class 2 Recall
Edwards Lifesciences Crimpers
see related information
Date Posted April 17, 2013
Recall Status1 Terminated on September 16, 2013
Recall Number Z-1134-2013
Recall Event ID 64747
Premarket Approval
PMA Numbers
P100041 P110021
Product Classification Aortic Valve, Prosthesis, Percutaneously Delivered - Product Code NPT
Product Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Code Information Models 9100CR23, all lot numbers.
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper, Utah 84020-9414
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Rob Becker
801-565-5203
Manufacturer Reason
for Recall
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
FDA Determined
Cause 2
TRAINING: Use Error
Action Edwards Lifesciences notified customers via letter and instructed them to maintain the device in its protective unit carton until ready for use and to inspect the pouch for holes or tears prior to use as instructed in the product's labeling. If any holes or tears are found, customers are instructed to contact Edwards Customer Service to arrange for return and replacement of damaged product.
Quantity in Commerce 5,472 units
Distribution Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
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.
PMA Database PMAs with Product Code = NPT and Applicant = EDWARDS LIFESCIENCES, LLC.
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