Medical device recalls Moderate risk

Cypress Medical Products LLC recalls Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Recall date
August 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3185-2024
FDA classification
Class II
Brand / firm
Cypress Medical Products LLC
Sold / distributed
US Nationwide distribution.

Why it was recalled

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

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

What was recalled

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

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