FDAFDA · Food and drugs·Recall number Z-0071-2018
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.
Published November 15, 2017 · Recall initiated: September 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recommended storage temperature on the label is incorrect.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Aaren Scientific Inc.
- Distributor
- Nationwide distribution including Puerto Rico.
- Lot
- Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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