The Recall Desk
HighFDA (Devices)·Z-2015-2012·Announced 2012-07-25

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.

What this means for you

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
Affected units
279

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically: