FDA-Device2017-11-08Class II

Alcon Custom Pak

Alcon Research, LTD.
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.

Sold states
States in the US - WI, NY, MO
Affected count
33 units
Manufactured in
9965 Buffalo Speedway, N/A, Houston, TX, United States
Products
Alcon Custom Pak

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2018

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