Medline Procedure Kits With Leaking Sterile Solution Bottles Recalled Nationwide
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled due to leaking at the seal interface. The defective bottles may compromise sterility, affecting procedure kits 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 Class II medical device recall affects sterile solutions in procedure kits, which are risk-of-harm products where no illnesses or injuries have been reported, meeting the rubric criterion for score 3.
Plain-English summary
Medline Industries is recalling procedure kits labeled as OL OCULAR (REF DYNJ906183K, UDI/DI 10195327385521). The kits contain Sterile Water and Sterile 0.9% Normal Saline bottles that have been identified as defective.
The Sterile Water and Normal Saline bottles leak at the interface where the peel-foil meets the bottle opening. This defect can compromise the sterility of the solutions, potentially allowing contamination during medical procedures.
The affected lot (23LME299) was distributed nationwide in the United States and internationally to Panama and Canada. Healthcare facilities and consumers using these kits should stop using affected units immediately and contact Medline Industries or consult the FDA recall notice for replacement or return instructions.
The recalled product
- Product
- Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaking-container
- 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 10195327385521 (EA)40195327385522 (CS)
- Lot Numbers: 23LME299
Distribution
Distributed nationwide across the United States.
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