Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling Centurion procedure kits with plastic syringes affected by an FDA Safety Alert. The syringes may leak, break, or develop quality issues that could pose risks to patient health.
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 medical device recall. The source identifies quality defects (leaks, breakage) that may pose patient health risks but does not report any actual illnesses or injuries. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, which qualifies for a High severity score.
Plain-English summary
Medline Industries, LP is recalling Centurion procedure kits labeled as Umbilical Vessel Tray (Pack Number UVT1100). The kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
These medical convenience kits are distributed worldwide. Leaks, breakage, and other quality issues have been identified in the plastic syringes that may pose a risk to patient health.
The recall includes four lot numbers: 2021032280, 2021072680, 2021092780, and 2022011080.
The recalled product
- Product
- Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (5)
- UVT1100
- Lot Number 2021032280
- Lot Number 2021072680
- Lot Number 2021092780
- Lot Number 2022011080
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 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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