Z-1234-2025 Class II Ongoing
FDA device recall Z-1234-2025 was initiated by Scientia Vascular, Inc. on January 2, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 120 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 devices
Product 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
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.
Distribution Pattern
U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.
Code Information
Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451