American Surgical Cotton Balls Recalled Due to Packaging Sterility Defect
American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.
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 packaging defects compromise sterility, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 7 boxes of American Surgical Cotton Balls-Non-Strung 1/8" (Ref Number: 31-07). These products are intended for use as neurosurgical and nonneurosurgical sponges. The recall is being conducted because the product packaging is defective, which compromises the sterility of the items.
The affected lot number is 2015/12 AW. The distribution pattern for this recall is worldwide, including the United States and the following countries: Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected products immediately and contact American Surgical Company for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 7
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 (1)
- Lot numbers: 2015/12 AW
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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