Sam Brusco, Associate Editor06.14.24
The U.S. Food and Drug Administration (FDA) has deemed Getinge’s recall of Vaporizer Sevoflurane Maquet Filling as Class I.
The company recalled the filling after reports of discoloration and/or corrosion in the vaporizer after the fill was used with low water content sevoflurane made by Piramal or Baxter. Sevoflurane used in the vaporizer can degrade to hydrogen fluoride, a toxic and hazardous acid. This can be a risk if it’s inhaled or contacts the skin.
Inhaling hydrogen fluoride can irritate the respiratory tract and lead to lung edema or hypocalcemia. Contact with the skin can cause blistering, superficial ulceration, and/or hypomagnesemia.
The FDA has thus far received reports of two incidents and no injuries or deaths related to the issue.
Getinge’s May 1 Urgent Medical Device Removal letter instructed customers to stop using the vaporizer with sevoflurane provided by Piramal and Baxter. Users were also instructed not to use the vaporizer if it was ever used with those types of sevoflurane, even if not in current use with those products.
Vaporizers with the identified product code and serial numbers (6682282, serial numbers 17003-23454) can still be used with AbbVie Ultane after certifying its use on the Medical Device Recall Response Form included with the letter. Vaporizer use should be discontinued if it’s uncertain whether it was used with Piramal or Baxter Sevoflurane.
If an agent looks cloudy and yellowish at any time, use of the affected vaporizer should immediately be stopped.
The Vaporizer Sevoflurane is used exclusively for containing, vaporizing, and blending liquid Sevoflurane with oxygen to start and maintain general anesthesia. The manufacturers Abbvie, Baxter, and Piramal produce different formulations of Sevoflurane.
The company recalled the filling after reports of discoloration and/or corrosion in the vaporizer after the fill was used with low water content sevoflurane made by Piramal or Baxter. Sevoflurane used in the vaporizer can degrade to hydrogen fluoride, a toxic and hazardous acid. This can be a risk if it’s inhaled or contacts the skin.
Inhaling hydrogen fluoride can irritate the respiratory tract and lead to lung edema or hypocalcemia. Contact with the skin can cause blistering, superficial ulceration, and/or hypomagnesemia.
The FDA has thus far received reports of two incidents and no injuries or deaths related to the issue.
Getinge’s May 1 Urgent Medical Device Removal letter instructed customers to stop using the vaporizer with sevoflurane provided by Piramal and Baxter. Users were also instructed not to use the vaporizer if it was ever used with those types of sevoflurane, even if not in current use with those products.
Vaporizers with the identified product code and serial numbers (6682282, serial numbers 17003-23454) can still be used with AbbVie Ultane after certifying its use on the Medical Device Recall Response Form included with the letter. Vaporizer use should be discontinued if it’s uncertain whether it was used with Piramal or Baxter Sevoflurane.
If an agent looks cloudy and yellowish at any time, use of the affected vaporizer should immediately be stopped.
More about the Vaporizer Sevoflurane Maquet Filling
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.The Vaporizer Sevoflurane is used exclusively for containing, vaporizing, and blending liquid Sevoflurane with oxygen to start and maintain general anesthesia. The manufacturers Abbvie, Baxter, and Piramal produce different formulations of Sevoflurane.