Alcon Research LLC recalls Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925…

Recall date

February 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1293-2025

FDA classification

Class II

Brand / firm

Alcon Research LLC

Sold / distributed

US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.

Why it was recalled

Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09