American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 27 boxes of Ultracot 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 medical device where defective packaging compromises sterility, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
American Surgical Company is recalling 27 boxes of Ultracot 70 mm x 10090 mm neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that compromises sterility.
The affected products are identified by Reference Number 23-24 and Lot Numbers 2015/09 BZ and 2015/11 BA. These sponges 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 Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 27
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 BZ 2015/11 BA
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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