Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI:
Summary
The FDA issued a Class I for Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the follo by Getinge Usa Sales Inc. Reason: A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/.
Details
Source
Device Recall
External ID
Z-0468-2022
Action Date
2022-01-19
Status
Ongoing
Category
device
Product Description
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318
Lot/Code Info: UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968
Quantity Affected: 50 US; 898 OUS
Reason for Recall
A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.
Distribution
Worldwide distribution - US Nationwide distribution in the states of VA and MO. The countries of Austria, Bahrain, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Estonia, Iraq, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Morocco, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-09
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 106 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-0468-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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