Getinge Usa Sales Inc: Device Recall

Recall Details

Recall Number

Z-1074-2025

Classification

Class I

Product Type

Device

Recalling Firm

Getinge Usa Sales Inc

Status

Ongoing

Date Initiated

01/15/2025

Location

Wayne, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6 units

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.

Product Description

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.

Distribution Pattern

Domestic distribution to Kentucky and Connecticut.

Other Recalls by Getinge Usa Sales Inc

• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• Class II: Risk 10/03/2024
  Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay

View all recalls by Getinge Usa Sales Inc →