Device product
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
Z-0800-2025
Product summary
- Event
- Event 95909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-0800-2025
Official wording
Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Code information: LOT NUMBER: 24F1638
Distribution pattern: IL, FL, SC. PA, AL Foreign: Netherlands
Derived failure modes
-
Potency or specification failure
out of specification