Recall Z-0354-2023— Alcon Research, LLC

Name: FDA recall Z-0354-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Class II · Ongoing

Class II FDA medical device recall by Alcon Research, LLC, initiated 2022-10-31. It names one FDA 510(k) clearance: K880961. Product: Alcon Custom Pak Surgical Procedure Pack. Reason: Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots..

Recalling firm: Alcon Research, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-10-31
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 Pack

Reason for recall

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

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