Medline Sterile Solution Bottles Recalled for Leaking Seals
Medline is recalling sterile water and normal saline bottles in procedure kits due to leaking seals that compromise sterility. Affected units were distributed to healthcare facilities in the United States, Panama, and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall involving a risk-of-harm product—sterile solution bottles with compromised seals—where no illnesses or injuries have been reported. The defect creates a potential contamination risk for medical procedures.
Plain-English summary
Medline Industries, LP is recalling Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles included in procedure kits labeled "T AND A PACK -LF" (Reference DYNJ85792). The recall affects 30 units identified by lot number 24BBB747.
The bottles were found to be leaking at the interface where the peel-foil seal meets the bottle opening. This defect compromises the sterility of the solution, which is essential for safe medical use.
The affected kits were distributed in the United States, Panama, and Canada. Healthcare facilities should verify their inventory for lot number 24BBB747 and reference number DYNJ85792.
Users of affected products should cease use immediately and contact Medline Industries for return and replacement instructions.
The recalled product
- Product
- Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- leaking-seal
- contamination-risk
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.
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