Maquet Cardiovascular, LLC Recall: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-1
Maquet Cardiovascular, LLC Recall: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-1 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Maquet Cardiovascular, LLC; Product: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z; Reason for recall: Deviations in the manufacturi
| Recalling firm | Maquet Cardiovascular, LLC |
|---|---|
| Product | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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, Luxembou |
| Recall initiated | 20241016 |
| Recall number | Z-0486-2025 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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