ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00607567700543
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Maquet Cardiovascular, LLC
- Reason for Recall:
- The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Product Codes/Lot Numbers:
UDI-DI: 00607567700543
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2272-2023
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