ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use

FDA device recall Z-0558-2025 · posted 2024-11-26 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

Action taken

On October 25, 2024, the firm notified customers of the recall via letters titled "Olympus America, Inc. IMMEDIATE ACTION REQUIRED RECALL". Customers were informed that the specified lot of kits may contain the affected lot of Single Use Biopsy Valve MAJ-1555 recalled by Olympus. The missing sterile and manufacturing lot numbers and expiration dates can be found on the outer box or zipper bag label. Affected product should not be used if you are unable to determine the expiration date. Customers should locate and quarantine all product from affected lot. Customers should complete the response form provided by the firm. Upon receipt of the completed form, the firm will provide over-labels to place on affected inventory, with instructions for staff to remove the affected component prior to using the kit. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

FDE

Quantity affected

100

Distribution

US Nationwide distribution in the state of NY.

Date initiated

2024-10-25

Date posted

2024-11-26

Location

Northfield, IL