Medical device recalls Moderate risk

NelDerm Hydrogel Dressing Product #: HB66T recalled over foreign material

Recall date
February 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Nelson Innovaions, Llc recalls NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Recall number
Z-2083-2020
FDA classification
Class II
Brand / firm
Nelson Innovaions, Llc
Sold / distributed
CA, NC, PR

Why it was recalled

Foreign material near or along the edge of the hydrogel adhesive within the pouch 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

NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T

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