Recall Z-1708-2016— Stryker Sustainability Solutions

Name: FDA recall Z-1708-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-28

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-04-28, terminated 2016-06-29. It names one FDA 510(k) clearance: K012708. 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.. Reason: Mislabeled for size.

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Terminated: 2016-06-29
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K012708 — ELECTROPHYSIOLOGY CATHETERAlliance Medical Corp.·cleared 2002-08-13

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 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.