Recall Z-1627-2018 ยท FRO Dressing, Wound, Drug
Conseal International, Inc.
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.
| Date | Apr 25, 2018 |
| Status | Terminated |
| 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. |
| Root cause | 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 | 384 |
| Distribution | US Distribution to the states of : AL, MS, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.