Recall Z-0071-2018— Aaren Scientific Inc.

Name: FDA recall Z-0071-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Aaren Scientific Inc., initiated 2017-09-01, terminated 2018-05-01. It names one FDA 510(k) clearance: K123888. Product: 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: The recommended storage temperature on the label is incorrect..

Recalling firm: Aaren Scientific Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2018-05-01
Firm location: Ontario, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123888 — Z CARTRIDGE IOL DELIVERY SYSTEMAaren Scientific, Inc.·cleared 2013-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.