Recalls / —

—#203877

Product

Medline Leg bag, REF URO12573

FDA product code

FAQ — Bag, Urine Collection, Leg, For External Use, Sterile

Device class

Class 1

Medical specialty

Gastroenterology, Urology

Affected lot / code info

UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001

Why it was recalled

Undeclared latex

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US and Panama

Timeline

Recall initiated

2023-10-19

Posted by FDA

2024-09-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #203877. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.