Device 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
Z-0525-2019
Product summary
- Firm
- ASO, LLC
- Event
- Event 81555
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 218 cases (72, 10-ct boxes per case)
- Official record key
device-enforcement:Z-0525-2019
Official wording
Reason: Potential that gauze pads may not be fully sterilized
Code information: ASO Item No. 780655, Batch/Lot # 2384-20180524
Distribution pattern: Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
Derived failure modes
-
Unknown
Potential that gauze pads may not be fully sterilized