FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged...
FDA Recall #Z-1747-2022 — Class II — August 2, 2022
Product Description
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
Reason for Recall
Sterility with new cotton source not validated
Recalling Firm
Carwild Corporation — New London, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
90 CASES (4500 EACHES)
Distribution
US Nationwide
Code Information
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated