Medline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles
Medline Industries is recalling Non Sterile I&D Kit procedure kits (Lot 23KDB283) because Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide, including the US, Panama, and Canada.
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 involving a medical device with a manufacturing defect (leaking bottles). No illnesses or injuries are reported in the source text, and the hazard is a packaging/integrity issue rather than a high-risk contamination or structural failure. This meets the criteria for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling Medline Non Sterile I&D Kit procedure kits (Reference DYKM1438, UDI/DI 10889942529964 and 40889942529965, Lot 23KDB283). The recall affects 240 units distributed worldwide to the US, Panama, and Canada.
The kits contain Sterile Water and Sterile 0.9% Normal Saline bottles that leak at the interface where the peel-foil meets the bottle opening. This leaking condition was identified during the review of the product.
Healthcare facilities and individuals who have received these kits should stop using them and contact Medline Industries for replacement or further instructions.
The recalled product
- Product
- Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- leaking-packaging
- defective-seal
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 10889942529964 (EA) 40889942529965 (CS)
- Lot Numbers: 23KDB283
Distribution
Distributed nationwide across the United States.
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