GE Healthcare Recalls Invasive Blood Pressure Care Cables
GE Healthcare is recalling 279 invasive blood pressure care cables due to a faulty O-ring that prevents correct blood pressure monitoring.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that inhibits correct blood pressure monitoring, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 279 units of its Invasive Blood Pressure Care Cables. The affected products include Product ID Numbers 2016995-001, 2016995-002, 2016995-003, and 2016995-004. These cables are designed for use with a Spectramed / BD invasive blood pressure transducer.
The recall was initiated after GE Healthcare received complaints regarding a potential safety issue. The problem is caused by the use of an incorrect O-ring, which results in a faulty mating between the cable and the transducer. This defect inhibits the correct monitoring of blood pressure measurements.
The affected units were distributed worldwide, including nationwide in the United States and in various international countries. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 279
Distribution
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