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.
Reported: May 20, 2020 Initiated: October 7, 2019 #Z-1928-2020
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 35
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Edwards Lifesciences, LLC. Units affected: 35.
Why was this product recalled? ▼
Intermittent communication due to inconsistent crimping of connectors onto cables.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1928-2020.
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