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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Recall Number Z-1135-2013
Classification Class II
Code Info Models 9100CR26, all lot numbers.
Product Distributed Qty 6,117 units
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.

Event Detail

Event Id 64747
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.