Medical device recalls Moderate risk

Quanta System, S.p.A. recalls Quanta System Sterile Optical Laser Fiber, single use

Recall date
April 27, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1843-2021
FDA classification
Class II
Brand / firm
Quanta System, S.p.A.
Sold / distributed
Nationwide distribution via 6 US distributors

Why it was recalled

Product sterility is potentially compromised.

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

What was recalled

Quanta System Sterile Optical Laser Fiber, single use

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