American Surgical Company, LLC has recalled 390 units of Americot 20-01S neurological sponges (6mm x 6mm) because the X-ray detectable barium strip (radio-opaque marker) can detach from the sponge. These sponges are used to protect neural tissue during surgery. While no injuries have been reported, a detached marker may remain in the surgical field, requiring surgeons to spend extra time locating and removing it, which can delay the procedure. Hospital staff should stop using the affected sponges and contact the manufacturer to arrange for their return.
The barium strip used to make the sponge visible on X-rays can separate from the device during a procedure. This defect creates a risk of leaving a foreign object in the patient's body or causing significant delays in surgery as medical teams must locate and retrieve the detached marker.
Neurological sponges for use in the protection of neural tissue during surgery.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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