Device product
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Z-1488-2026
Product summary
- Event
- Event 98240
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95,882 boxes (20 per box)
- Official record key
device-enforcement:Z-1488-2026
Official wording
Reason: Potential for rubber fragment detachment during use.
Code information: Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
rubber fragment