PYRClass II
Neuraxial Administration Set - Intrathecal Delivery
General Hospital · 21 CFR 880.5440
Neuraxial Administration Sets used to deliver fluids to the intrathecal space.
MDR events9All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances0All time
Recent MDR events
9 adverse event reports on file
- BACLOFENJun 17, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00009
- BACLOFENApr 15, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00008
- BACLOFENApr 6, 2026Malfunction3012625281-2026-00007
- BACLOFENMar 25, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00006
- BACLOFENMar 24, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00005
- BACLOFENMar 20, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00004
- BACLOFENMar 19, 2026MalfunctionAmneal Pharmaceuticals3012625281-2026-00001
- BACLOFENMar 19, 2026Malfunction3012625281-2026-00003
- CADD SOLIS COMM MODULE SILEX 802.11Jan 8, 2025MalfunctionSmith¿s Medical Asd, Inc.3012307300-2025-00411
Event type breakdown
Malfunction9
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.