Recall Z-0053-2018— Alcon Research, LTD.

Name: FDA recall Z-0053-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-08

Class II · Terminated

Class II FDA medical device recall by Alcon Research, LTD., initiated 2017-08-08, terminated 2019-08-05. It names one FDA 510(k) clearance: K880961. Product: Alcon Custom Pak. Reason: Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks..

Recalling firm: Alcon Research, LTD.
Classification: Class II
Status: Terminated
Initiated: 2017-08-08
Terminated: 2019-08-05
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

Reason for recall

Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

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