—#213285

Product

Medline Sterile Water, USP, 100mL, REF RDI30295

FDA product code: FRO — Dressing, Wound, Drug
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K173276
Affected lot / code info: UDI/DI 10884389338230 (EA) 40884389338231 (CS), Lot Numbers: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA031, 23LJA089, 24AJA095, 24AJA157, 24CJA089, 24IJA004, 24IJA036, 24JJA164, 24KJA008, 24KJA051, 24KJA108.

Why it was recalled

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email Recalls@Medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama and Canada.

Timeline

Recall initiated: 2025-03-19
Posted by FDA: 2025-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.