# FDA recall Z-1627-2018

> **Conseal International, Inc.** · Class II · device recall initiated 2018-04-25.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1627-2018
- **Recalling firm:** Conseal International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-25
- **Report date:** 2018-05-09
- **Termination date:** 2019-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2018

## Citation

> AI Analytics. FDA recall Z-1627-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1627-2018. Source: US FDA. Licensed CC0.

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