United StatesMaquet Critical Care AB Flow anesthesia machines—models Flow‑i C20 (6677200, 6888520), Flow‑i C30 (6677300, 6888530), Flow‑i C40 (6677400, 6888540), Flow‑c (6887700) and Flow‑e (6887900) with software versions 4.8, 4.10, and 4.11—are recalled. The devices were recalled after events where the vaporizer was activated but the anesthetic agent was not delivered, which can result in insufficient anesthesia and possible intraoperative awareness. These units were distributed worldwide, including across many U.S. states.
What's being recalled
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Recalling firm: Maquet Critical Care AB, Solna, Sweden.
How to identify it
Flow-i C20 6677200 / UDI-DI 07325710001349 Flow-i C30 6677300 / UDI-DI 07325710001363 Flow-i C40 6677400 / UDI-DI 07325710001318 Flow-i C20 6888520 / UDI-DI 07325710010617 Flow-i C30 6888530 / UDI-DI 07325710010624 Flow-i C40 6888540 / UDI-DI 07325710010631 Flow-c 6887700 / UDI-DI 07325710009765 Flow-e 6887900 / UDI-DI 07325710010457 Software versions 4.8, 4.10, and 4.11.
The hazard
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)