FDA-Device2017-04-26Class II

Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Alcon Research, Ltd.
Hazard

Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.

Sold states
US Nationwide Distribution
Affected count
561,702
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2017

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