Medline procedure packs with syringes recalled due to leaks and breakage
Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk 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 classification applies. No illnesses or injuries have been reported. The hazard—leaks and breakage in medical syringes—represents a significant risk of harm, warranting a High severity score.
Plain-English summary
Medline Industries, LP has recalled procedure packs containing Shenli syringes due to manufacturing defects. The recalled products include CVC DOUBLE LUMEN 16CM packs (Pack Number ECVC8105) and VANTEX 7FR 3L 20CM CVC BUNDLE US packs (Pack Number ECVC8045).
These syringes are affected by an FDA Safety Alert issued on March 19, 2024, regarding plastic syringes with leaks, breakage, and other quality issues. These defects may pose a risk to patient health.
A total of 1,679,067 units were distributed worldwide. The specific affected lot numbers are: ECVC8105 (Lot Numbers 2023052690 and 2023100490) and ECVC8045 (Lot Number 2023110990).
Healthcare facilities and clinicians should stop using affected products immediately and contact Medline Industries for instructions on replacement or return of the recalled materials.
The recalled product
- Product
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- Affected units
- 1,679,067
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)
- ECVC8105
- Lot Number 2023052690
- Lot Number 2023100490
- ECVC8045
- Lot Number 2023110990
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 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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