Alcon Research, LTD. recalls Alcon Custom Pak

Recall date

August 8, 2017

Source

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

Recall number

Z-0053-2018

FDA classification

Class II

Brand / firm

Alcon Research, LTD.

Sold / distributed

States in the US - WI, NY, MO

Why it was recalled

Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

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