Recall Z-0195-2016— Alcon Research, Ltd.

Name: FDA recall Z-0195-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-21

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2015-09-21, terminated 2016-03-24. It names one FDA 510(k) clearance: K880961. Product: Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.. Reason: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves..

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Terminated: 2016-03-24
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K880961 — ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories·cleared 1988-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.