Recall Z-0095-2021— Alcon Research, LLC

Name: FDA recall Z-0095-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-24

Class II · Terminated

Class II FDA medical device recall by Alcon Research, LLC, initiated 2020-08-24, terminated 2021-11-17. It names one FDA 510(k) clearance: K880961. Product: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.. Reason: The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids..

Recalling firm: Alcon Research, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Terminated: 2021-11-17
Firm location: Houston, 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

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Reason for recall

The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.

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