Alcon Research, Ltd. recalls Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessorie…

Recall date

March 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1837-2017

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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