American Surgical Policot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers two 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 medical device where packaging defects compromise sterility, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling two boxes of Policot 1/2" x 2" sponges (Ref Number: 90-29) used for neurosurgical and nonneurosurgical procedures. The recall is due to defective product packaging that compromises sterility.
The affected lot number is 2016/01 AF. 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.
Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for instructions on return or replacement.
The recalled product
- Product
- American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 2
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: 2016/01 AF
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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