Medical device recalls Moderate risk

Medela Inc recalls Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists o…

Recall date
December 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0773-2020
FDA classification
Class II
Brand / firm
Medela Inc
Sold / distributed
AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA

Why it was recalled

Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

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

What was recalled

Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

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