Reported Nov 13, 2024 · Ongoing
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during…
American Surgical Company, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Surgical Company, LLC · 45 Congress St Ste 153 · Salem, MA · 01970-5998
Is this the product you have?
- Americot 20-01S (1/4" x 1/4")
- or 6mm x 6mmNeurological sponges for use in the protection of neural tissue during surgery
- Ref20-01S ¿ x ¿
- inches or 6mm x 6mm) ComponentN/A
- Lot codes and dates
6 of 6 products · 6 lot codes
Recalled lot codes, grouped by product number Lot Number Expiration Date Lot codes and dates 202303 AQ 2028/03/31
202306 AP 2028/06/30
202310 BO 2028/10/31
202312 AY 2028/12/31
202405 AE 2029/05/31
202406 AQ 2029/06/30
- Amount recalled
- 390 units
Where it was sold
Why it was recalled
Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
This product could cause temporary or reversible health problems — stop using it.
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