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.
This recall has been terminated (originally issued July 25, 2018).
- 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
- Official Source
- View on FDA website ↗
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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