Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40
Summary
The FDA issued a Class I for Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Compone by Getinge Usa Sales Inc. Reason: Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalati.
Details
Source
Device Recall
External ID
Z-1877-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
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.
Lot/Code Info: Part Number 6682282; UDI/DI: 07325710000212: Serial Numbers: 17003 - 23454.
Quantity Affected: 120 units (US)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-01
Company
Wayne, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1877-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29