Recall Z-1627-2018— Conseal International, Inc.
Class II · Terminated
Class II FDA medical device recall by Conseal International, Inc., initiated 2018-04-25, terminated 2019-04-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Conseal International, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-25
- Terminated
- 2019-04-02
- Firm location
- Norwood, MA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.