FDA recall Z-1928-2020

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 for recall

Intermittent communication due to inconsistent crimping of connectors onto cables.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.

Key facts

Status

Terminated

Initiation date

2019-10-07

Report date

2020-05-20

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1928-2020