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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