American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 442 boxes of Delicot 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 is classified as FDA Class II. The hazard involves compromised sterility of medical devices, which poses a risk of harm, but the source text does not report specific illnesses or injuries, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Surgical Company is recalling 442 boxes of American Surgical Delicot 10 mm x 13 mm sponges (Ref Number: 63-03). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which may compromise the sterility of the devices.
The affected lots include 2015/08 CL, 2015/09 BT, 2015/10 BT, 2015/11 BG, 2015/12 AI, 2015/12 CF, 2015/12 CQ, 2016/01 AK, and 2016/01 AA. 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. No specific illnesses or injuries are reported in the source text. Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for instructions on returning the product.
The recalled product
- Product
- American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 442
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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