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Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip

FDA device recall Z-1209-2014 · posted 2014-03-14 · Terminated

Recall details

Recalling firm
Atricure Inc
Reason for recall
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Action taken
On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
HBT
Quantity affected
46 units
Distribution
Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
Date initiated
2014-01-23
Date posted
2014-03-14
Date terminated
2014-05-13
Location
West Chester, OH

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