Medical device recalls Moderate risk

Elasto-Gel Absorbent Wound Dressing recalled over mold contamination

Recall date
November 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Southwest Technologies Inc recalls Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Recall number
Z-0687-2020
FDA classification
Class II
Brand / firm
Southwest Technologies Inc
Sold / distributed
CA, GA, IL, KS, NY, OH, TN, TX, VA

Why it was recalled

Elasto-Gel Wound Dressing may be contaminated with mold.

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

What was recalled

Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

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