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Class 2 Device Recall Fixation Kit N20 |
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Date Initiated by Firm |
July 16, 2015 |
Date Posted |
August 19, 2015 |
Recall Status1 |
Terminated 3 on January 29, 2016 |
Recall Number |
Z-2417-2015 |
Recall Event ID |
71739 |
510(K)Number |
K093154
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Product Classification |
Monitor, carbon-dioxide, cutaneous - Product Code LKD
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Product |
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures. |
Code Information |
Model #: 905-873 Lots: 407221, 407231, 407241, 407251, 408041, 408191, 408201, 408211, 408231, 408232, 408261, 408271, 409021, 409101, 409231, 409291, 410021, 410141, 410281, 411171, 411201, 411261, 412021, 412111, 412161, 412201, 501081, 501131, 501191, 501311, 502031, 502101, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504031, 504081, 504111, 504271, 505041, 505061, 505141, 505181 |
Recalling Firm/ Manufacturer |
Radiometer America Inc 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact |
Radiometer America Technical Support 440-871-8900 Ext. 4
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Manufacturer Reason for Recall |
When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Radiometer sent a Product Notification letter dated July 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
In the letter the firm requests that inventory be checked and removed for any the identified lot numbers for Fixation kit N20. The firm requests that the products be discarded. The letter states to complete p.2 and return it to their Radiometer representative.
If you have any questions contact Radiometer America Technical Support at 1-800-736-0600 opt.4. |
Quantity in Commerce |
4244 kits |
Distribution |
Worldwide Distribution - US Distribution and to the countries of : Canada, Spain, France, Great Britain, Philippines, Netherlands, Japan, China, Australia, Denmark, South Africa, Germany, Qatar, Turkey, Hong Kong, Costa Rica, Austria, Finland, Indonesia, Norway, Malaysia, Belgium, Czech Republic, Hungry, United Arab Emirates, Poland, Colombia, Belgium and Malta. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LKD and Original Applicant = RADIOMETER MEDICAL APS
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