BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1627-2018 · Initiated April 25, 2018

    Recall

    Recall Number
    Z-1627-2018
    Event Number
    79962
    Firm
    Conseal International, Inc.
    FEI Number
    3004610547
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 25, 2018
    Terminated
    April 2, 2019
    Address
    90 Kerry Place, Suite 2, Norwood, MA, 02062-4765

    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.

    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.

    Distribution

    US Distribution to the states of : AL, MS, and MA.

    Quantity

    384