Recall Z-0068-2019— Surge Medical Sales, LLC (DBA Surge Cardiovascular)

Name: FDA recall Z-0068-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-18

Class II · Terminated

Class II FDA medical device recall by Surge Medical Sales, LLC (DBA Surge Cardiovascular), initiated 2018-07-18, terminated 2019-04-04. It names one FDA 510(k) clearance: K964199. Product: Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.. Reason: The device was built with the rigid insertion stylet instead of the flexible stylet..

Recalling firm: Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Terminated: 2019-04-04
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K964199 — CHASE CORONARY SINUS PERFUSION CANNULAChase Medical, Inc.·cleared 1997-03-19

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

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Reason for recall

The device was built with the rigid insertion stylet instead of the flexible stylet.

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