Z-1710-2025 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
May 7, 2025
Initiation Date
March 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 units

Product Description

Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

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.

Distribution Pattern

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

Code Information

UDI/DI 10653160144250 (EA) 40653160144251 (CS), Lot Numbers: 23JBU525