Z-1074-2025Class I

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30...

Name: Z-1074-2025 Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30...
Creator: Getinge Usa Sales Inc
Published: 2025-01-15
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2025-01-15 / Open, Classified / root cause: design

FDA source

Getinge Usa Sales Inc began a recall of Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia on 2025-01-15. FDA classified it as Class I and gives the reason as "Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1074-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-07
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Root cause tag: design
FDA root cause: Device Design
Action: Getinge notified consignees on 01/15/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were provided additional information which is complementary to the existing user manual and were instructed to ensure all affected product inventory has been quarantined, consignees are entitled to credit/replacement, the recall information is forwarded to affected personnel and any customers if it was further distributed and complete and return the provided URGENT MEDICAL DEVICE RECALL RESPONSE FORM.
Quantity in commerce: 6 units
Distribution: Domestic distribution to Kentucky and Connecticut.
Product codes and lots: Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1074-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-07

Product code BSZ

K191027Class IIFlow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)