American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury (such as loss of sterility in surgical products) are rated as Severe.
Plain-English summary
American Surgical Company is recalling 34 boxes of American Surgical Cotton Balls-Strung 1/8" (Ref Number: 30-07). These products are used as neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that compromises the sterility of the cotton balls.
The affected lot numbers are 2015/11 AL, 2015/12 AS, 2015/12 BD, and 2015/12 DJ. The products were distributed worldwide, including the United States, 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.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected products and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 34
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: Lot Number 2015/11 AL 2015/12 AS 2015/12 BD 2015/12 DJ
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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