Z-1627-2018 Class II Terminated
FDA device recall Z-1627-2018 was initiated by Conseal International, Inc. on April 25, 2018 and is designated Class II. 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 o… The recall status is terminated (terminated April 2, 2019). Affected quantity: 384.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- April 25, 2018
- Termination Date
- April 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 384
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.
Distribution Pattern
US Distribution to the states of : AL, MS, and MA.
Code Information
Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.