Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
- 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:
- Scientia Vascular, Inc.
- Reason for Recall:
- Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Product Codes/Lot Numbers:
Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1234-2025
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