Reported Jul 10, 2019 · Ongoing
CLEO Patient Monitor /Tranquility VS Patient Monitor
Infinium Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Infinium Medical, Inc · 12151 62nd St Ste 5 · Largo, FL · 33773-3702
Is this the product you have?
- CLEO Patient Monitor /Tranquility VS Patient Monitor
- Lot codes and dates
96 of 96 codes
Serial Numbers - A18094501812A18014501391A18014600053A18014600070A18014600080A18014501432A18014501438A17074501202A17084501263A17024500996A160545005214500008245000084450000854500005745000058A1 8094501659A17044501052A17024500972A160104500653A160104500674A160104500685A160104500701A16084500604A16084500605A15104500320A15 104500407A1510450025745000083450000434500004445000045A17024500996A18094501642A18094501674A18094501696A1707450122745000072480000014800000248000003A1 8094501639A18094501652A18094501657A18094501702A18094501719A18044600082A18044600083A18044600087A18044600089A18044600092A17124501378A17124501384A17124501385A17124501386A17124501387A17024800002A17024800004A17024800006A17024800007
- Amount recalled
- 95 devices
Where it was sold
Why it was recalled
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
This product could cause temporary or reversible health problems — stop using it.
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