Medline Vascular IVC Filter Placement Kits Recalled for Syringe Defects
Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with no reported illnesses or injuries. The potential hazard (leaks and breakage in medical syringes) qualifies as a risk-of-harm product where injury has not yet been reported, justifying High severity per the rubric.
Plain-English summary
Medline Industries is recalling medical convenience kits containing plastic syringes (Pack Number DYKMBNDL37AH, Lot Number 22IBB075) distributed worldwide.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified in the syringes that may pose a risk to patient health.
Healthcare facilities with affected kits should discontinue use and contact Medline Industries for replacement or return instructions. Patients who received care using these kits should contact their healthcare provider if they experience complications.
The recalled product
- Product
- Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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)
- DYKMBNDL37AH
- Lot Number 22IBB075
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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