Z-1705-2025 Class II Ongoing
FDA device recall Z-1705-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 19, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 963054 units.
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
- 963054 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Code Information
UDI/DI 10884389338230 (EA) 40884389338231 (CS), Lot Numbers: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA031, 23LJA089, 24AJA095, 24AJA157, 24CJA089, 24IJA004, 24IJA036, 24JJA164, 24KJA008, 24KJA051, 24KJA108.