Z-1209-2014 Class II Terminated
FDA device recall Z-1209-2014 was initiated by Atricure Inc on January 23, 2014 and is designated Class II. Reason for recall: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. The recall status is terminated (terminated May 13, 2014). Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2014
- Initiation Date
- January 23, 2014
- Termination Date
- May 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
Reason for Recall
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Distribution Pattern
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.
Code Information
Lot Number MFR-0424-1