Class II — Safe N Simple, LLC
| Recalling firm | Safe N Simple LLC |
|---|---|
| Registered facility | SAFE N SIMPLE LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The sterilization process used was unqualified. |
| Product | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345 |
| Quantity | 125 cases |
| Distribution | CA |
| Initiated | 2018-08-22 |
| Classified | 2018-11-07 |
| Terminated | 2020-03-17 |
| Recall number | Z-0401-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Safe N Simple, LLC (Z-0401-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81150/
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