Recall Z-0525-2019— ASO, LLC

Name: FDA recall Z-0525-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-16

Class II · Ongoing

Class II FDA medical device recall by ASO, LLC, initiated 2018-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box. Reason: Potential that gauze pads may not be fully sterilized.

Recalling firm: ASO, LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-10-16
Firm location: Sarasota, FL, United States

Product description

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

Reason for recall

Potential that gauze pads may not be fully sterilized

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