Edwards Lifesciences Crimpers recall: Sterility Concern
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Why was Edwards Lifesciences Crimpers recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Models 9100CR26, all lot numbers.
- Product
- Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 6,117 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.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)