Class 2 Device Recall CLEO Patient Monitor /Tranquility VS Patient Monitor

• Date Initiated by Firm: May 31, 2019
• Create Date: July 02, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1926-2019
• Recall Event ID: 82999
• 510(K)Number: K142244
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• Product: CLEO Patient Monitor /Tranquility VS Patient Monitor
• Code Information: Serial Numbers - A18094501812, A18014501391, A18014600053, A18014600070, A18014600080, A18014501432, A18014501438, A17074501202, A17084501263, A17024500996, A16054500521, 45000082, 45000084, 45000085, 45000057,45000058, A1 8094501659, A17044501052, A17024500972, A160104500653, A160104500674, A160104500685, A160104500701, A16084500604, A16084500605, A15104500320, A15 104500407, A15104500257, 45000083, 45000043, 45000044, 45000045, A17024500996, A18094501642, A18094501674, A18094501696, A17074501227, 45000072, 48000001, 48000002, 48000003, A1 8094501639, A18094501652, A18094501657, A18094501702, A18094501719, A18044600082, A18044600083, A18044600087, A18044600089, A18044600092, A17124501378, A17124501384, A17124501385, A17124501386, A17124501387, A17024800002, A17024800004, A17024800006, A17024800007, A17024800008, A17024800012, A17024800013, A17024800018, A17024800021, A17024800022, A17024800024, A17024800028, A17024800030, A1702480003 1, A17024800032, A17024800039, A17024800043, A17024800046, A17024800048, A17024800050, A17024800009, A17024800014, A17024800015, A17024800016, A17024800017, A17024800019, A17024800020, A17024800025, A17024800026, A17024800027, A17024800029, A17024800033, A17024800034, A17024800037, A17024800038, A17024800040, A17024800042, A17024800044, A17024800047, A17024800049.
• FEI Number: 3007513035
• Recalling Firm/ Manufacturer: Infinium Medical, Inc; 12151 62nd St Ste 5; Largo FL 33773-3702
• For Additional Information Contact: George J. Anello; 866-918-5434 Ext. 109
• Manufacturer Reason for Recall: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
• FDA Determined Cause: Labeling False and Misleading
• Action: Infinium Medical, Inc. notified customers on about 05/31/2019 via "URGENT: MEDICAL DEVICE RECALL" letter sent through email and certified letter. Instructions included to remove all temperature modules from the CLEO & Tranquility VS Patient Monitors and destroyed. They were also requested to complete and return the Medical Device Recall Return Response Form to QARA@infiniummedical.com. Once the response form is received, a new IFU and standalone temperature monitor will be provided. Questions and comments can be sent to Mr. George Anello during regular business hours (8:00 AM - 04:30 PM EST) at QARAinfiniummedical.com or by phone at l-866-918-8434 ext. 109.
• Quantity in Commerce: 95 devices
• Distribution: Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.
• Total Product Life Cycle: TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MWI