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Recall Observatory FDA recall evidence

Device product

Medline Sterile Water, USP, 100mL, REF RDI30295

Z-1705-2025

March 19, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96630
Status
Ongoing
Classification
Class II
Quantity
963054 units
Official record key
device-enforcement:Z-1705-2025

Official wording

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.

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.