Medline procedure packs recalled due to syringe quality issues
Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and other quality issues that 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: The recall involves a medical device with identified quality issues (leaks, breakage) that may pose a risk to patient health, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 1,679,067 units of procedure packs containing Shenli syringes. The affected products are labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A, with Lot Number 2020012890. These medical convenience kits were distributed worldwide.
The recall is being conducted because the plastic syringes contained 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, which may pose a risk to patient health.
Healthcare facilities and consumers should stop using the affected procedure packs and contact Medline Industries, LP for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Packs
- 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 (2)
- DYNDA1431A
- Lot Number 2020012890
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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