Events

Recall of Nanosil Spray Gel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conseal International, Inc..

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
    79962
  • Event Risk Class
    Class 2
  • Event Number
    Z-1627-2018
  • Event Initiated Date
    2018-04-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164041
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    A recent fda inspection of the firm revealed significant current good manufacturing practices (cgmp) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
  • Action
    ConSeal sent an Urgent Medical Device Recall letter dated April 25, 2018, to its customers via email. The letter instructed customers to locate the affected product, quarantine, and return it to the firm. Customers were also instructed to complete and return the customer response form, and inform any users the customer distributed the product to. Customers may contact the firm by calling 782-352-0490. For further questions, please call (781) 278-0010.

Device

Nanosil Spray Gel
  • Model / Serial
    Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, MS, and MA.
  • Product Description
    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 || The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
  • Manufacturer
    Conseal International, Inc.

Manufacturer

Conseal International, Inc.
  • Manufacturer Address
    Conseal International, Inc., 90 Kerry Place, Suite 2, Norwood MA 02062-4765
  • Manufacturer Parent Company (2017)
    Conseal International, Inc.
  • Source
    USFDA