Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Vaporizer Sevoflurane Maquet Filling

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Vaporizer Sevoflurane Maquet Fillingsee related information
Date Initiated by FirmMay 01, 2024
Date PostedMay 31, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1877-2024
Recall Event ID 94502
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductVaporizer 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 Part Number 6682282; UDI/DI: 07325710000212: Serial Numbers: 17003 - 23454.
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information ContactStephanie Moretti
973-709-7170
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce120 units (US)
DistributionDomestic: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
-
-