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

FDA device recall Z-1877-2024 · posted 2024-05-31 · Open, Classified

Recall details

Recalling firm

Getinge Usa Sales Inc

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.

Action taken

On May 1, 2024 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken by customer: Until further notice, do NOT use the Vaproizer with Sevoflurane provided by Poramal and Baxter Sevoflurane. Do NOT use the Vaporizer if it was ever used with Sevoflurane Piramal and/or Baxter Sevoflurane, even if it currently is used with AbbVie Ultane. Our records indicate that you have received the Vaporizer Sevoflurane, Maquet Filling having one or more of the serial numbers that are affected by this recall. 1. Please examine your inventory immediately to determine if you have any of the Vaporizer Sevoflurane, Maquet Filling with the product codes/serial numbers listed in this notice. The Product Code/REF Number and serial number (SN) are found on the label located underneath each vaporizer. Should you have any affected product, please remove from areas of use. 2. If you have ONLY used Vaporizer Product Code/REF Number 6682282, serial number 17003-23454 with AbbVie Ultane, you can continue to use the vaporizer, by certifying that you only use AbbVie Ultane on the Medical Device Recall Response Form. If you are uncertain whether you have previously used the vaporizer with Piramal Sevoflurane and/or Baxter Sevoflurane, discontinue use of the vaporizer. 3. Persuant to the previous recall for the Vaporizer Product Code/REF Number 6886601, you can continue to use this vaporizer so long as it has ONLY been used with Abbvie Ultane. If you are uncertain whether you have previously used the vaporizer with Piramal Sevoflurane and/or Baxter Sevoflurane, discontinue use of the vaporizer. 4. If at any time, the agent in the vaporizer looks cloudy and yellowish, you should immediately stop use of the affected vaporizer. 5. If you have affected product you are entitled to a credit or replacement. Please contact Getinge Customer Service at 888-943-8872 (press option 2) to request a return authorization (RMA) and shipping instructions to return any affected product. Pack

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BSZ

Quantity affected

120 units (US)

Distribution

Domestic: CA, CO, IN, MO, OR, VA, WA. International: Aruba, Australia, Austria, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Bulgaria, Chile, China, Costa Rica, Czech Republic, Denmark, Estonia, Finl

Date initiated

2024-05-01

Date posted

2024-05-31

Location

Wayne, NJ

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