Medical device recalls Moderate risk

Safe N Simple, LLC recalls Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

Recall date
August 22, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0400-2019
FDA classification
Class II
Brand / firm
Safe N Simple, LLC
Sold / distributed
CA

Why it was recalled

The sterilization process used was unqualified.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

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