American Surgical Americot Blue Sponges Recalled for Packaging Defect
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 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 involves a risk-of-harm product (sterile medical device) where the hazard is compromised sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
American Surgical Company is recalling 262 boxes of Americot Blue 1/2" x 1/2" sponges (Ref Number: 20-04S). These neurosurgical and nonneurosurgical sponges are being recalled because defective product packaging may compromise sterility.
The affected lots are 2015/08 CM, 2015/09 AJ, 2015/10 BI, 2015/11 AY, and 2015/12 CJ. 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.
Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 262
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: 2015/08 CM 2015/09 AJ 2015/10 BI 2015/11 AY 2015/12 CJ
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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