American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 24 boxes of Delicot non-xray sponges because defective packaging compromises sterility.
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 harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 24 boxes of American Surgical Delicot non-xray 5 mm x 8 mm sponges (Ref Number: 63-01). The product is used for neurosurgical and nonneurosurgical sponges.
The recall was initiated because the product packaging is defective, which compromises the sterility of the sponges. The affected lot numbers are 2015/10 BY and 2015/10 CV.
The product was distributed worldwide, including the United States, 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. Users should stop using the affected sponges and contact the manufacturer for instructions.
The recalled product
- Product
- American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 24
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 BY 2015/10 CV
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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