Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Reported: November 13, 2024 Initiated: September 18, 2024 #Z-0287-2025
Product Description
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Reason for Recall
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.
Details
- Recalling Firm
- American Surgical Company, LLC
- Units Affected
- 390 units
- Distribution
- CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
- Location
- Salem, MA
Frequently Asked Questions
What product was recalled? ▼
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A. Recalled by American Surgical Company, LLC. Units affected: 390 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0287-2025.
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