American Surgical Company, LLC: 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) Compo

Hazard

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 from the source

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. Distribution: CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy Quantity: 390 units Lot/code info: UDI-DI: 10749915000039 Lot Number Expiration Date: 2023/03 AQ 2028/03/31; 2023/06 AP 2028/06/30; 2023/10 BO 2028/10/31; 2023/12 AY 2028/12/31; 2024/05 AE 2029/05/31; 2024/06 AQ 2029/06/30

UPC codes

10749915000039

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.