FDA Device Recall Z-0260-2024: Alcon Research, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0260-2024.

Recall Res Number

Z-0260-2024

Recalling Firm / Manufacturer

Alcon Research, LLC

FEI Number

1000117501

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-09-07

Date Posted

2023-11-07

Date Terminated

N/A

Product Code

LRO

Event Number

93115

Product Quantity

120 packs

Product Description Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Reason for Recall Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

Action Details On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.

Distribution Pattern US: VA OUS: None

Code Information / Serial Numbers LOT # : 160NMU, UDI: (01)10380653302278

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Medical Device Recall: Z-0260-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer