Edwards HemoSphere Oximetry Cable Recalled for Inconsistent Connector Crimping
Edwards Lifesciences is recalling 35 HemoSphere oximetry cables due to intermittent communication caused by inconsistent crimping of connectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves intermittent communication due to manufacturing defects (inconsistent crimping) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Edwards Lifesciences, LLC is recalling 35 units of the HemoSphere oximetry cable (REF/UDI: HEMOXSC100/(01)00690103196986). The recall is due to intermittent communication resulting from inconsistent crimping of connectors onto the cables.
The affected cables were distributed worldwide, including nationwide in the United States and in Germany, the Netherlands, and the United Kingdom. The specific serial numbers for the 35 recalled units are listed in the official recall documentation.
Healthcare providers and consumers should stop using the affected cables and contact Edwards Lifesciences for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- The cables with the following serial numbers (35) are recalled: 13710131
- 13710130
- 13710129
- 13710115
- 13710113
- 13710025
- 13710027
- 13710028
- 13710029
- 13710030
- 13710031
- 13710041
- 13710043
- 13710045
- 13710050
- 13710051
- 13710056
- 13710057
- 13710058
- 13710061
Distribution
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