Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling multiple convenience kits used in medical procedures due to plastic syringe defects including leaks and breakage. No injuries have been reported, but the defects 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: This is a Class II FDA medical device recall of syringes with identified quality defects (leaks and breakage) that pose direct risk to patient health. No illnesses or injuries have been reported, but these defects represent a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes affected by a March 19, 2024 FDA Safety Alert. The recalled kits are used in various medical procedures and are distributed worldwide.
The plastic syringes in these kits have been identified with quality issues including leaks and breakage. These issues may pose a risk to patient health during medical procedures.
The recall affects multiple product variants including PREP TRAY, STERILE PREP TRAY, ED PREP TRAY, PRE-OP PREP KIT, PILGRIM PREP TRAY, and specialty surgical and medical procedure kits. Multiple lot numbers of each product are affected.
Healthcare facilities and practitioners using affected products should verify lot numbers against the recall notice and contact their medical supplier or Medline Industries, LP for further information and instructions.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- 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)
- DYNDA1540
- Lot Number 23JBV995
- Lot Number 23GBA155
- Lot Number 23EBB508
- Lot Number 22LBK096
- Lot Number 22JBQ748
- Lot Number 22HBC421
- Lot Number 22DBP691
- Lot Number 22ABU584
- Lot Number 21BBI623
- Lot Number 20LBU589
- Lot Number 20KBL865
- Lot Number 20JBP526
- Lot Number 20IBD073
- Lot Number 20HBT535
- Lot Number 20HBQ630
- Lot Number 20HBB154
- Lot Number 2019050290
- Lot Number 2019061890
- Lot Number 2019071290
Distribution
Distribution scope not specified by the agency.
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