Recall Z-1928-2020— Edwards Lifesciences, LLC

Name: FDA recall Z-1928-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-07

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2019-10-07, terminated 2021-04-27. It names one FDA 510(k) clearance: K163381. Product: Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.. Reason: Intermittent communication due to inconsistent crimping of connectors onto cables..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Terminated: 2021-04-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163381 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC·cleared 2017-04-14

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

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

Reason for recall

Intermittent communication due to inconsistent crimping of connectors onto cables.

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