Tuesday, July 16, 2024

Anesthesia Device Recall: FDA Class I Warning for Vaporizer Sevoflurane Maquet Filling

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The Food and Drug Administration (FDA) has classified the recall of Vaporizer Sevoflurane Maquet Filling a part of the Flow anesthesia systems as a Class I recall, the most serious type, due to potential serious injuries or death. The affected product, identified by product code 6682282 and distributed serial numbers 17003 – 23454, was distributed from February 2, 2022, to March 29, 2024. A total of 120 devices were recalled in the U.S., with the recall initiated in April.

The Vaporizer Sevoflurane Maquet Filling is part of the Flow anesthesia systems, including Flow-i C20, C30, and C40 as well as Flow-c and Flow-e. It is used exclusively for containing, vaporizing, and blending liquid Sevoflurane with oxygen to start and maintain general anesthesia. Manufacturers Abbvie, Baxter, and Piramal produce different formulations of Sevoflurane. Getinge initiated the recall after reports of discoloration and corrosion within the vaporizer when used with low water content Sevoflurane from Piramal or Baxter.

Hazardous Degradation of Sevoflurane Prompts Urgent Recall of Anesthesia Vaporizers

The Sevoflurane may degrade into hydrogen fluoride, a toxic and hazardous acid posing risks to patients and health care professionals if inhaled or contacted. Inhalation can cause respiratory tract irritation, fluid buildup in the lungs, and severely low blood calcium levels. Skin contact may result in blistering, superficial ulceration, and low magnesium levels. Use of these devices may lead to serious injuries or death. Getinge has reported two incidents with no injuries or deaths.

Patients administered anesthesia with Vaporizer Sevoflurane Maquet Filling and health care professionals using these devices are affected. The recall’s urgent medical device removal letter, issued on May 1, 2024, instructs customers to stop using the vaporizer with Sevoflurane from Piramal and Baxter and to avoid using any vaporizer that has ever contained these products, even if not currently in use. Customers are advised to examine their inventory to identify the affected product, which can be found by checking the label underneath each vaporizer for the Product Code/REF Number and serial number. Affected products must be removed from use immediately.

Anesthesia

Affected Anesthesia Vaporizers Require Immediate Action and Return Authorization

Vaporizers identified with product code 6682282 and serial numbers 17003-23454 may continue to be used with AbbVie Ultane after certifying its use on the Medical Device Recall Response Form included with the recall letter. If it is uncertain whether a vaporizer was used with Piramal or Baxter Sevoflurane, it should be discontinued. Any vaporizer showing a cloudy and yellowish appearance must be stopped immediately. Customers will receive credit or replacements for affected products.

To request a return authorization (RMA) and shipping instructions, customers should contact Getinge Customer Service at 888-943-8872. The process for returning affected products includes packing them with appropriate return documents and arranging for pickup using the designated delivery service provider. Customers must enter the serial number and the RMA number provided by Customer Service on the Medical Device Recall Response Form included with the letter.

 

Resource: Food and Drug Administration, June 13, 2024

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