Medline Procedural Kits Recalled for Syringe Quality Defects
Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.
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 medical device recall with identified quality defects (leaks, breakage) that pose potential risk to patient health. No illnesses or injuries have been reported; per the rubric, this qualifies as High (3) severity—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP (Northfield) is recalling NEURO TRAY procedural kits, Pack Number DYNJ55909B, Lot Number 23IBB122. These medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.
The syringes have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health and could compromise the safety and effectiveness of medical procedures.
The recalled kits have been distributed worldwide. Healthcare providers and patients who possess these kits should immediately discontinue use and contact Medline Industries for guidance on proper disposal, return, or replacement options.
The recalled product
- Product
- Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- leaks
- breakage
- quality-defect
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)
- DYNJ55909B
- Lot Number 23IBB122
Distribution
Distribution scope not specified by the agency.
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