Recall Z-0287-2025 ยท HBA Neurosurgical Paddie
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) Component: N/A
| Date | Nov 1, 2024 (initiated Sep 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | American Surgical issued Urgent Medical Device Recall Letter on 9/26/24 via email. Letter states reason for recall, health risk and action to take: Effective immediately, American Surgical Company, LLC (ASC) requests your assistance. We ask that all lots listed in the table above within your inventory immediately be discontinued for use. We also ask the inventory to be quarantined, counted, and discarded. " Report any complaint to ASC Customer Service 1-800-343-0060 or email: customerservice@americansurgical.com " The product code and lot number can be found on the individual product pouch |
| Quantity | 390 units |
| Distribution | CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854714 | X-RAY DETECTABLE COTTON BALLS American Silk Sutures, Inc., Dec 17, 1985 |