FDA Medical devices recall ·
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z recall
- Recall number
- Z-0485-2025
- Date
- (initiated October 16, 2024)
- Company / brand
- Maquet Cardiovascular, LLC
45 Barbour Pond Dr, Wayne, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10,778 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0485-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.