Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
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 is classified as FDA Class II, and the source text states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, fitting the rubric 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 recall covers 32 different kit types, including biopsy trays, bone marrow packs, and fetoscopy 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.
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, stop using 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) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack N
- 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)
- CDS840215O
- Lot Number 21HBJ135
- Lot Number 21JBS174
- Lot Number 22ABB090
- Lot Number 22ABS124
- Lot Number 22EBA066
- Lot Number 22GBQ007
- Lot Number 22GBQ009
- Lot Number 22HBU942
- Lot Number 23ABD369
- Lot Number 23CBO683
- Lot Number 23FBT988
- Lot Number 23GBI919
- Lot Number 23JBK910
- Lot Number 24ABE598
- Lot Number 20LBA006
- Lot Number 21ABQ774
- Lot Number 21ABR763
- Lot Number 21ABT392
- Lot Number 21CBM879
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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