Recall Z-0485-2025— Maquet Cardiovascular, LLC
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2024-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z. Reason: 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..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-16
- Firm location
- Wayne, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.