ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns
ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the hazard is a risk of harm (infection) due to potential lack of sterilization, but no injuries or illnesses have been reported.
Plain-English summary
ASO, LLC is voluntarily recalling Family Wellness First Aid Sterile Gauze Pads, 3 in x 3 in, 10 count. The recall was initiated because there is a potential that the gauze pads may not be fully sterilized.
The affected product is identified by ASO Item No. 780655 and Batch/Lot # 2384-20180524. A total of 218 cases, containing 72 10-count boxes per case, were distributed nationwide to Arkansas, Florida, Iowa, Indiana, Kentucky, New York, Oklahoma, Texas, Utah, and Virginia.
Consumers who have purchased this product should stop using it and contact ASO, LLC for further instructions or a refund.
The recalled product
- 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
- Manufacturer
- ASO, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- ASO Item No. 780655
- Batch/Lot # 2384-20180524
Distribution
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