Recalls / —

—#214095

Product

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012

Why it was recalled

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An URGENT MEDICAL DEVICE PRODUCT RECALL notification letter dated 5/15/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.comRecall Reference #: R-25-096-FGX2 Recall Code: 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the state of VA.

Timeline

Recall initiated

2025-05-15

Posted by FDA

2025-06-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.