FDA recall Z-0053-2018

Product

Alcon Custom Pak

Reason for recall

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.

Distribution

States in the US - WI, NY, MO

Key facts

Status

Terminated

Initiation date

2017-08-08

Report date

2017-11-08

Termination date

2019-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

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