Z-0525-2019 Class II Ongoing
FDA device recall Z-0525-2019 was initiated by ASO, LLC on October 16, 2018 and is designated Class II. Reason for recall: Potential that gauze pads may not be fully sterilized The recall status is ongoing. Affected quantity: 218 cases (72, 10-ct boxes per case).
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2018
- Initiation Date
- October 16, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 cases (72, 10-ct boxes per case)
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
Distribution Pattern
Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
Code Information
ASO Item No. 780655, Batch/Lot # 2384-20180524