American Surgical Recalls Sponges Due to Packaging Sterility Defect
American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products 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 risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
American Surgical Company is recalling 103 boxes of Americot Blue 1" x 3" neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that may compromise the sterility of the sponges.
The affected products include lot numbers 2015/10 AL, 2015/11 BZ, 2015/12 CC, and 2016/01 AB. These sponges were distributed nationwide in the United States and internationally to Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, the 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 how to return the product.
The recalled product
- Product
- American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 103
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: 2015/10 AL 2015/11 BZ 2015/12 CC 2016/01 AB
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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