Medline procedure kits recalled for leaking sterile water and saline bottles
Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. No illnesses or injuries are reported in the source text, and the hazard is a container defect (leaking) rather than a high-risk pathogen or acute injury risk. This fits the profile of a moderate-severity recall with a manufacturing defect and precautionary measure.
Plain-English summary
Medline Industries, LP is recalling Medline procedure kits labeled as T AND A PACK -LF (REF DYNJ85792) due to a defect causing leaking. The sterile water and sterile 0.9% normal saline bottles included in these kits leak at the interface where the peel-foil meets the bottle opening.
The affected kits were distributed worldwide, including throughout the United States and to Panama and Canada. The lot number involved is 24BBB747, with 30 units recalled. The product can be identified by UDI/DI 10195327552350 (EA) or 40195327552351 (CS).
Consumers who have these kits should stop using them and contact Medline Industries, LP for instructions on return or disposal.
The recalled product
- Product
- Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 30
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 (2)
- UDI/DI 10195327552350 (EA) 40195327552351 (CS)
- Lot Numbers: 24BBB747
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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