American Surgical Delicot Sponges Recalled for Packaging Sterility Compromise
American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 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 defective packaging compromises sterility, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
American Surgical Company is recalling 4 boxes of Delicot non-xray 10 mm x 13 mm sponges, Reference Number 63-03. These neurosurgical and nonneurosurgical sponges are subject to recall because the product packaging is defective, which compromises the sterility of the devices.
The affected lot number is 2015/10 CB. The products were distributed worldwide, including in the United States and various international locations such as 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 immediately and contact American Surgical Company for instructions on how to return the product.
The recalled product
- Product
- American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 4
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 CB
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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