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Terminated

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

FDA Recall Z-2015-2012 · Posted 2012-07-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2012-06-12
Date Terminated2013-12-05
Product Quantity279

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.

Firm Action

GE Healthcare sent a Urgent Medical Device Correction letter dated June 12, 2012, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Inforamtion. Advised customers to discontinue use, further distribution and to contact their customers. Please return any defective Invasive Blood Pressure Cables by isolating all affected product and completing the attached Confirmation form/fax back per its instructions. This step is required to confirm receipt of communications with all customers. If you have any questions or concerns regarding this notification, please contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation: 8:00 am EST to 6:00 pm EST. .

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042642AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)Ge Medical Systems Information Technologies · 2004-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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