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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64770
Product Type Devices
Status Ongoing
Recalling Firm Transonic Systems Inc
City Ithaca
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. Lot numbers: 102810, 010311 and 111810. Class II Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. 195 units total (140 units Domestic, 55 units Foreign) Z-1147-2013