Device product
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Z-1708-2016
Product summary
- Event
- Event 73983
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 devices
- Official record key
device-enforcement:Z-1708-2016
Official wording
Reason: Mislabeled for size
Code information: Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017
Distribution pattern: Distributed in the state of NY and the country of Canada.
Derived failure modes
-
Labeling or packaging
Mislabeled