Recall Z-0467-2019— Stryker Sustainability Solutions

Name: FDA recall Z-0467-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-23

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2018-08-23, terminated 2021-02-04. It names one FDA 510(k) clearance: K112292. Product: Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.. Reason: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2018-08-23
Terminated: 2021-02-04
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K112292 — REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERStryker Sustainability Solutions·cleared 2011-10-21

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

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.

Reason for recall

Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

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