Z-0071-2018 Class II Terminated
FDA device recall Z-0071-2018 was initiated by Aaren Scientific Inc. on September 1, 2017 and is designated Class II. Reason for recall: The recommended storage temperature on the label is incorrect. The recall status is terminated (terminated May 1, 2018). Affected quantity: 786 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- September 1, 2017
- Termination Date
- May 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 786 boxes
Product Description
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.
Reason for Recall
The recommended storage temperature on the label is incorrect.
Distribution Pattern
Nationwide distribution including Puerto Rico.
Code Information
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.