Medical device recalls Moderate risk

Stradis Medical, LLC dba Stradis Healthcare recalls Surgicare Neuro Pack - Neurological Kit

Recall date
February 25, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0862-2022
FDA classification
Class II
Brand / firm
Stradis Medical, LLC dba Stradis Healthcare
Sold / distributed
US Nationwide distribution in the states of IN, TX, and PA.

Why it was recalled

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

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

What was recalled

Surgicare Neuro Pack - Neurological Kit

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