Recall Z-1877-2024— Getinge Usa Sales Inc

Name: FDA recall Z-1877-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-01

Class I · Ongoing

Class I FDA medical device recall by Getinge Usa Sales Inc, initiated 2024-05-01. It names one FDA 510(k) clearance: K191027. Product: Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.. Reason: 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..

Recalling firm: Getinge Usa Sales Inc
Classification: Class I
Status: Ongoing
Initiated: 2024-05-01
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB·cleared 2020-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.