Z-1794-2020 Class II Terminated

Recalled by Alcon Research LLC — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
July 25, 2018
Termination Date
April 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102 packs

Product Description

Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

Reason for Recall

There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.

Distribution Pattern

There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.

Code Information

Lot #2128524H