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U.S. Department of Health and Human Services

Class 2 Device Recall AV Loop Kit

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 Class 2 Recall
AV Loop Kit
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on March 05, 2014
Recall Number Z-1147-2013
Recall Event ID 64770
Premarket Notification
510(K) Number
K080116 
Product Classification Computer, Diagnostic, Pre-Programmed, Single-Function - Product Code DXG
Product 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.
Code Information Lot numbers: 102810, 010311 and 111810.
Recalling Firm/
Manufacturer
Transonic Systems Inc
34 Dutch Mill Rd
Warren Road Business Park
Ithaca, New York 14850-9785
For Additional Information Contact David Klementowski
607-257-5300 Ext. 201
Manufacturer Reason
for Recall
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Transonic Systems Inc. sent an Urgent: Medical Device Recall dated March 27, 2013 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine, discontinue use and return any recalled product via FedEx. Transonic Systems Inc. has offered to reimburse the firm for the return of these recalled products by check or credit memo for the returned goods and postage. Transonic Systems Inc. has requested that if a firm has further distributed any of the above lots, that they immediately contact their accounts, inform them of the recall, and have them return their outstanding recalled stocks to you. Transonic Systems Inc. have included copies of the product labeling and a Recall Return Response Form in their packet. Completed Recall Return Response Forms should be faxed to 607-257-5310.
Quantity in Commerce 195 units total (140 units Domestic, 55 units Foreign)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXG and Original Applicant = TRANSONIC SYSTEMS, INC.
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