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Open, Classified

CLEO Patient Monitor /Tranquility VS Patient Monitor

FDA Recall Z-1926-2019 · Posted None

Recalling FirmInfinium Medical, Inc
Recall StatusOpen, Classified
Product CodeMWI
Date Initiated2019-05-31
Product Quantity95 devices

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.

Firm 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 [email protected]. 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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