Medical Convenience Kits with Plastic Syringes Recalled Due to Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.
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: FDA Class II recall involving syringes with quality defects (leaks, breakage) that pose potential risk to patient health. No illnesses or injuries have been reported in the source text, so the severity reflects the hazard potential without documented harm.
Plain-English summary
Medline Industries is recalling medical convenience kits that contain plastic syringes due to quality defects identified in a related FDA Safety Alert issued on March 19, 2024. The affected kits may experience leaks, breakage, and other quality issues.
These quality defects may pose a risk to patient health. The recall is classified as FDA Class II and affects 1,679,067 units that have been distributed worldwide.
Consumers who have received affected convenience kits should stop using the plastic syringes and contact Medline Industries or their healthcare provider for guidance on replacement products. Healthcare facilities and distributors should verify whether they have received affected lots and take appropriate steps to quarantine and return the products.
The recalled product
- Product
- See RES description
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- quality-defect
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)
- 00-398650AJ
- Lot Number 23ABN193
- Lot Number 23ABN291
- Lot Number 23EBQ823
- Lot Number 23FBJ579
- Lot Number 23FBT136
- Lot Number 23IBB919
- Lot Number 23KBE097
- Lot Number 23LBS258
- 00-398725AL
- Lot Number 19BBA371
- Lot Number 19CBE645
- Lot Number 19DBR240
- Lot Number 19EBK403
- Lot Number 19FBU700
- Lot Number 19GBR148
- 00-398725AN
- Lot Number 21FBS869
- Lot Number 21JBN432
- Lot Number 21LBK643
Distribution
Distribution scope not specified by the agency.
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