RecallDepth

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.

Company
Alcon Research Llc
Recall Initiated
July 25, 2018
Terminated
April 24, 2020
Recall Number
Z-1794-2020
Quantity
102 packs
Firm Location
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

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

Lot / Code Info

Lot #2128524H

Root Cause

Employee error

Action Taken

The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.

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