Medline Recalls Medical Convenience Kits with Defective Plastic Syringes
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.
What this means for you
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 medical devices with quality defects (leaks, breakage) that may pose a risk to patient health, but the source text does not report any 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 specific medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected products include a wide range of procedure trays and kits, such as pressure tubing, arterial line kits, biopsy trays, chest tube insertion trays, and vascular access kits, distributed worldwide.
The recall is being conducted because leaks, breakage, and other quality issues have been identified in the plastic syringes contained within these kits. These defects may pose a risk to patient health. The source text does not specify the number of affected units or report any specific injuries or illnesses.
Healthcare facilities and consumers should check their inventory for the specific pack numbers and lot numbers listed in the official recall notice. If you have these products, do not use them and contact Medline Industries for instructions on how to return or dispose of the affected kits.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE
- 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 (20)
- 81239
- Lot Number 24DDA646
- Lot Number 24BDA159
- Lot Number 24ADA118
- Lot Number 23LDB385
- Lot Number 23FDB922
- Lot Number 23FDB435
- Lot Number 23CDC570
- Lot Number 23BDA790
- Lot Number 23ADA161
- Lot Number 22LDA211
- Lot Number 22KDA441
- Lot Number 22HDA985
- Lot Number 22GDB017
- Lot Number 22FDA642
- Lot Number 22BDB971
- Lot Number 22BDB067
- Lot Number 22BDA725
- Lot Number 21LDA117
- Lot Number 21KDB172
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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