Recall Z-1705-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1705-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-19

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-19. It names one FDA 510(k) clearance: K173276. Product: Medline Sterile Water, USP, 100mL, REF RDI30295. Reason: 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-03-19
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.·cleared 2018-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline Sterile Water, USP, 100mL, REF RDI30295

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.