Device product
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Z-1747-2022
Product summary
- Event
- Event 90808
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90 CASES (4500 EACHES)
- Official record key
device-enforcement:Z-1747-2022
Official wording
Reason: Sterility with new cotton source not validated
Code information: UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Sterility with new cotton source not validated