FDA recall Z-1747-2022

Carwild Corporation · Class II · 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

Reason for recall

Sterility with new cotton source not validated

Distribution

US Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-08-02
Report date: 2022-09-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: New London, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1747-2022