FDA-Device2018-12-12Class II

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

ASO, LLC
Hazard

Potential that gauze pads may not be fully sterilized

Sold states
Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
Affected count
218 cases (72, 10-ct boxes per case)
Manufactured in
300 Sarasota Center Blvd, N/A, Sarasota, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0525-2019

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