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GE Healthcare, LLC recalls GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995
Recalled July 25, 2012 · FDA recall Z-2015-2012 · GE Healthcare
Hazard
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. · FDA Class II
Units
279
Sold at
Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA.
Description
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.
Product
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →