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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Recall Number Z-2015-2012
Classification Class II
Code Info Product ID Number Lot Code 2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C
Product Distributed Qty 279
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.

Event Detail

Event Id 62123
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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