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
Recall
- Recall Number
- Z-0287-2025
- Event Number
- 95464
- Firm
- American Surgical Company, LLC
- FEI Number
- 1221144
- Product Code
- HBA
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 18, 2024
- Posted
- November 1, 2024
- Address
- 45 Congress St, Ste 153, Salem, MA, 01970-5998
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
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.
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: [email protected] " The product code and lot number can be found on the individual product pouch and carton. " Please respond to this request by the deadline in the form below and return the completed form to [email protected] or Fax: 1-781-595-5460 even if you do not have any inventory that remains. " If you distribute this product, please forward them a copy of this communication and notify ASC Customer Service immediately. Further information and support: " For general questions regarding this communication, contact Customer Service at 800-343-0060 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday.
CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
390 units