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Vaporizer Sevoflurane Maquet Filling, Product code/REF… recallZ-1877-2024 · Getinge Usa Sales Inc · initiated May 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1877-2024
Status
Open, Classified
Initiated by the company
May 1, 2024
Posted by the FDA
May 31, 2024
Recalling firm
Getinge Usa Sales Inc
Quantity
120 units (US)
Product code
BSZ
FDA submissions
K191027
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, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Macedonia, Malaysia, Mexico, Moldavia, Morocco, Mozambique, Namibia, Netherlands, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Vietnam Please note that a list of foreign consignees was not provided by the manufacturer and it is not available at this time.

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.

Code information (models, lots, serial numbers)

Part Number 6682282; UDI/DI: 07325710000212: Serial Numbers: 17003 - 23454.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K191027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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