Z-0380-2017 Class II Terminated
FDA device recall Z-0380-2017 was initiated by Stryker Sustainability Solutions on Oct 6, 2016 and is designated Class II. Reason for recall: The EP Catheters may be mislabeled for French size during reprocessing. The recall status is terminated (terminated Dec 16, 2016). Affected quantity: 4 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2016
- Initiation Date
- Oct 6, 2016
- Termination Date
- Dec 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product Description
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Reason for Recall
The EP Catheters may be mislabeled for French size during reprocessing.
Distribution Pattern
U.S. distribution to the following; AZ, MN and MO.
Code Information
Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0380-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026