Z-1708-2016 Class II Terminated
FDA device recall Z-1708-2016 was initiated by Stryker Sustainability Solutions on Apr 28, 2016 and is designated Class II. Reason for recall: Mislabeled for size The recall status is terminated (terminated Jun 29, 2016). Affected quantity: 18 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Apr 28, 2016
- Termination Date
- Jun 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 devices
Product Description
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Reason for Recall
Mislabeled for size
Distribution Pattern
Distributed in the state of NY and the country of Canada.
Code Information
Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1708-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026