Reported May 20, 2020 · Terminated
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Oxymetry Cable, Rxonly
- REF/UDIHEMOXSC100/(01)00690103196986 -
- Product UsageThe 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
- Lot codes and dates
- The cables with the following
- serial numbers (35) are recalled
1371013113710130137101291371011513710113137100251371002713710028137100291371003013710031137100411371004313710045137100501371005113710056137100571371005813710061137100621371006313710064137100661371006913710070137100841371008613710089137100921371009313710094137100981371009913710100
- Amount recalled
- 35
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Intermittent communication due to inconsistent crimping of connectors onto cables.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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