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Z-1143-2013 Class II Terminated

Recalled by Elana, Inc. — Columbia, MD

FDA device recall Z-1143-2013 was initiated by Elana, Inc. on February 14, 2013 and is designated Class II. Reason for recall: Distribution of an unapproved device into interstate commerce. The recall status is terminated (terminated May 9, 2013). Affected quantity: 3 devices.

Recall Details

Product Type: Devices
Report Date: April 24, 2013
Initiation Date: February 14, 2013
Termination Date: May 9, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 devices

Product Description

Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

Reason for Recall

Distribution of an unapproved device into interstate commerce.

Distribution Pattern

Distributed in the states of Pennsylvania, Texas, and New York.

Code Information

Model 280, S/N 776, S/N 706, S/N 758