Z-1794-2020 Class II Terminated
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