Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

FDA device recall Z-1712-2025 · posted 2025-05-01 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NSB

Quantity affected

2220 units

Distribution

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

Date initiated

2025-03-19

Date posted

2025-05-01

Location

Northfield, IL