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FDAFDA · Food and drugs·Recall number Z-0053-2018

Alcon Custom Pak

Published November 8, 2017 · Recall initiated: August 8, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Alcon Research, LTD.
Distributor
States in the US - WI, NY, MO
Lot
2033459H, 2034186H, 2034491H
Risk classification
Class II
Area (FDA)
device
Country
United States

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