Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Reported: November 27, 2024 Initiated: October 16, 2024 #Z-0485-2025
Product Description
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 10,778 units
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z. Recalled by Maquet Cardiovascular, LLC. Units affected: 10,778 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2024. Severity: Moderate. Recall number: Z-0485-2025.
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