The Recall Desk
HighFDA (Devices)·Z-0525-2019·Announced 2018-12-12

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.

What this means for you

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
Category
Medical Device — First Aid / Wound Care
Hazard

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

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same manufacturer · ASO, LLC

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Same hazard · infection risk

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