Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products 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 source identifies theoretical risks from leaks and breakage in medical syringes, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits containing plastic syringes distributed worldwide. The affected kits include multiple syringe product types with various pack numbers.
The syringes are affected by an FDA Safety Alert issued on March 19, 2024. Identified issues include leaks, breakage, and other quality problems in the plastic syringes that may pose a risk to patient health.
Multiple lot numbers of affected products have been identified and are detailed in the official FDA recall notice. These kits are used in medical and healthcare settings.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
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 (20)
- DYNJSYCPP10R
- Lot Number 22JBR164
- DYNJSYCPP10Y
- Lot Number 22JBR165
- NAM0004
- Lot Number 21DDB223
- Lot Number 21HDC569
- Lot Number 21IDB793
- Lot Number 21JDA347
- Lot Number 21LDA148
- OEM11623
- Lot Number 21GBQ995
- Lot Number 22BBC557
- Lot Number 22CBH284
- Lot Number 19BBF348
- Lot Number 19DBI184
- Lot Number 22EBE833
- Lot Number 19QBB707
- Lot Number 19FBK375
- Lot Number 19GBY960
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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