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U.S. Department of Health and Human Services

Class 2 Device Recall American Surgical Company

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 Class 2 Device Recall American Surgical Companysee related information
Date Initiated by FirmSeptember 18, 2024
Date PostedNovember 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0287-2025
Recall Event ID 95464
510(K)NumberK854714 
Product Classification Neurosurgical paddie - Product Code HBA
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 American Surgical Company, LLC
45 Congress St Ste 153
Salem MA 01970-5998
Manufacturer 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.
FDA Determined
Cause 2		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 and carton. " Please respond to this request by the deadline in the form below and return the completed form to customerservice@americansurgical.com 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.
Quantity in Commerce390 units
DistributionCA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBA
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