Events

Recall of Device Recall American Surgical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Surgical Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73734
  • Event Risk Class
    Class 2
  • Event Number
    Z-1797-2016
  • Event Initiated Date
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145368
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurosurgical paddie - Product Code HBA
  • Reason
    Product packaging defective compromising sterility.
  • Action
    American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: CustomerService@AmericanSurgical.com

Device

Device Recall American Surgical
  • Model / Serial
    Lot numbers:  2015/10 AN
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
  • Product Description
    American Surgical Uniqcot 1/2" x 3" || Ref Number: 67-09 || Product Usage: || Neurosurgical and Nonneurosurgical Sponges
  • Manufacturer
    American Surgical Company

Manufacturer

American Surgical Company
  • Manufacturer Address
    American Surgical Company, 45 Congress St, Salem MA 01970-5579
  • Manufacturer Parent Company (2017)
    American Surgical Company Llc
  • Source
    USFDA