Z-1235-2025 Class II Ongoing
FDA device recall Z-1235-2025 was initiated by Scientia Vascular, Inc. on January 16, 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: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
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 state of DE.
Code Information
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300