Infinium Medical, Inc CLEO Patient Monitor /Tranquility VS Patient Monitor Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CLEO Patient Monitor /Tranquility VS Patient Monitor
Brand
Infinium Medical, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Infinium Medical, Inc is recalling CLEO Patient Monitor /Tranquility VS Patient Monitor due to The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026