Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Custom Pak 9319-27. Single-use medical devices and accessories designed by Recalled by Alcon Research, Ltd. Due to The recalled lot of custom paks are labeled...

Date: September 21, 2015
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.

Affected Products

Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

Quantity: 5 units

Why Was This Recalled?

The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

Where Was This Sold?

This product was distributed to 1 state: VT

Affected (1 state)Not affected

About Alcon Research, Ltd.

Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report