Recall Z-2015-2012— GE Healthcare, LLC

Name: FDA recall Z-2015-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-06-12, terminated 2013-12-05. It names one FDA 510(k) clearance: K042642. Product: GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.. Reason: GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Terminated: 2013-12-05
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K042642 — AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)Ge Medical Systems Information Technologies·cleared 2004-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.

Reason for recall

GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.