Medline Sterile Water USP bottles recalled for leaking at peel-foil interface
Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a defect affecting product sterility, which the source identifies but does not connect to adverse health consequences, meeting the threshold for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling Medline Sterile Water, USP, 100mL bottles with the product reference number RDI30295. The recall affects 963,054 units distributed nationwide across the US, Panama, and Canada.
The bottles were identified as leaking at the interface of the peel-foil and bottle opening. This defect compromises the sterile integrity of the product.
The affected lot numbers are: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA031, 23LJA089, 24AJA095, 24AJA157, 24CJA089, 24IJA004, 24IJA036, 24JJA164, 24KJA008, 24KJA051, and 24KJA108. The UDI/DI is 10884389338230 (EA) and 40884389338231 (CS).
Consumers and healthcare providers in possession of affected bottles should stop using them and contact Medline Industries, LP for replacement or disposal instructions.
The recalled product
- Product
- Medline Sterile Water, USP, 100mL, REF RDI30295
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 963,054
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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