Recall Z-0380-2017— Stryker Sustainability Solutions
Class II · Terminated
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-10-06, terminated 2016-12-16. It names 2 FDA 510(k) clearances: K042074, K012708. Product: 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: The EP Catheters may be mislabeled for French size during reprocessing..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-06
- Terminated
- 2016-12-16
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
2 on FDA's record- K042074 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K012708 — ELECTROPHYSIOLOGY CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.