Medical device recalls Moderate risk

Aaren Scientific Inc. recalls AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on th…

Recall date
September 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0071-2018
FDA classification
Class II
Brand / firm
Aaren Scientific Inc.
Sold / distributed
Nationwide distribution including Puerto Rico.

Why it was recalled

The recommended storage temperature on the label is incorrect.

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

What was recalled

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.

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