Medline Procedure Packs with Defective Syringes Recalled Worldwide
Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.
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 involving defective medical syringes used in critical clinical procedures with potential for patient harm. No injuries or illnesses have been reported, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling approximately 1.7 million medical procedure packs containing Shenli syringes. The recalled products include CVC INSERT BUNDLE 16CM (Pack Number ECVC3260, Lot Number 2018052950) and VANTEX 7FR 3L 20CM CVC BUNDLE US (Pack Number ECVC8045, Lot Number 2023110290). These packs have been distributed worldwide.
The syringes are affected by an FDA Safety Alert issued on March 19, 2024, due to identified leaks, breakage, and other quality issues. These defects may pose a risk to patient health during medical procedures.
Healthcare facilities and providers who have received these procedure packs are affected by this recall. The recalled products are used for central venous catheter insertion and other clinical applications.
The recalled product
- Product
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure kits
- 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 (4)
- 1) ECVC3260
- Lot Number 2018052950
- 2) ECVC8045
- Lot Number 2023110290
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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