FDA Device

Alcon Custom Pak

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 You Should Do

Remedy

The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.

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Products

Alcon Custom Pak
Brand
Alcon Research, LTD. 9965 Buffalo Speedway
UPC
2033459H, 2034186H, 2034491H

Units Affected

33 units

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