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Class 2 Device Recall Mindray DS USA inc. |
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Date Initiated by Firm |
June 23, 2016 |
Create Date |
August 16, 2016 |
Recall Status1 |
Terminated 3 on March 28, 2017 |
Recall Number |
Z-2549-2016 |
Recall Event ID |
74704 |
510(K)Number |
K143195
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Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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Product |
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate. |
Code Information |
100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606 |
Recalling Firm/ Manufacturer |
Mindray DS USA, Inc. dba Mindray North America 800 Macarthur Blvd Mahwah NJ 07430-2001
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For Additional Information Contact |
Ms. Diane Arpino 800-288-2121
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Manufacturer Reason for Recall |
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers. |
Quantity in Commerce |
360 units |
Distribution |
Nationwide, Canada |
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 = MHX and Original Applicant = Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd
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