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U.S. Department of Health and Human Services

Class 2 Device Recall Nanosil Spray Gel

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  Class 2 Device Recall Nanosil Spray Gel see related information
Date Initiated by Firm April 25, 2018
Create Date May 03, 2018
Recall Status1 Terminated 3 on April 02, 2019
Recall Number Z-1627-2018
Recall Event ID 79962
Product Classification Dressing, wound, drug - Product Code FRO
Product 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.
Code Information Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
Recalling Firm/
Manufacturer		 Conseal International, Inc.
90 Kerry Place
Suite 2
Norwood MA 02062-4765
For Additional Information Contact Ms. Donna Gilmore
781-278-0010
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 384
Distribution US Distribution to the states of : AL, MS, and MA.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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