Recall Z-1747-2022— Carwild Corporation

Name: FDA recall Z-1747-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-02

Class II · Ongoing

Class II FDA medical device recall by Carwild Corporation, initiated 2022-08-02. FDA's recall record names no specific 510(k) clearance for this event. 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: Sterility with new cotton source not validated.

Recalling firm: Carwild Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-08-02
Firm location: New London, CT, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.