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Recall Observatory FDA recall evidence

Device product

Alcon Custom Pak

Z-0053-2018

August 08, 2017

Class II

Product summary

Firm
Alcon Research, LTD.
Event
Event 77965
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-0053-2018

Official wording

Reason: 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.

Code information: 2033459H, 2034186H, 2034491H

Distribution pattern: States in the US - WI, NY, MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.