Medline Sterile Water and Saline Bottles Leaking at Seal Interface
Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.
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 an FDA Class II recall of a sterile procedure product where a manufacturing defect compromises sterile integrity, creating a risk of contamination and harm. No reported illnesses or injuries are mentioned in the source, but the defect poses a direct risk to product safety and patient care.
Plain-English summary
Medline Industries, LP is recalling Medline procedure kits, including sterile water and sterile 0.9% normal saline bottles (REF DYNJ902002J, UDI/DI 10195327516079 and 40195327516070). A total of 159 units have been identified with a manufacturing defect.
The bottles are leaking at the interface where the peel-foil meets the bottle opening. This defect affects the integrity of the sterile fluid contained in the bottles.
The affected products were distributed worldwide, including US nationwide distribution, Panama, and Canada. The recalled lot numbers are 24ABC106, 23KBN892, and 23JBV265.
Customers who have received these products should stop using them immediately and contact Medline Industries for replacement or further guidance.
The recalled product
- Product
- Medline procedure kits, labeled as: HAND, REF DYNJ902002J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaking
- sterile-integrity-compromise
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 (4)
- UDI/DI 10195327516079 (EA) 40195327516070 (CS)
- Lot Numbers: 24ABC106
- 23KBN892
- 23JBV265
Distribution
Distributed nationwide across the United States.
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