FDA-Device2024-11-27Class II
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Maquet Cardiovascular, LLC
Hazard
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Sold states
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
Affected count
10,778 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2025Don't want to check this manually?
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