Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 68
Summary
The FDA issued a Class II for Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 66 by Maquet Critical Care AB. Reason: Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the p.
Details
Source
Device Recall
External ID
Z-2860-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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.
Quantity Affected: 408 US; 11,342 OUS
Reason for Recall
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Maquet Critical Care AB has 5 FDA actions in our database, including 4 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Critical Care AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Critical Care AB have FDA actions?
Maquet Critical Care AB has 5 FDA actions in our database, including 4 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2860-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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