American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 78 boxes 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 is classified as FDA Class II. The hazard involves compromised sterility of medical sponges, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 78 boxes of Americot Blue 1/2" x 1.5" sponges (Ref Number: 20-06S). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which compromises the sterility of the devices.
The affected lots are 2015/09 BR, 2015/12 BO, and 2015/12 BU. The products were distributed nationwide in the United States and internationally to 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.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using these sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 78
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: 2015/09 BR 2015/12 BO 2015/12 BU
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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