Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
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 an FDA Class II recall of medical devices used in clinical procedures where defects could potentially harm patients. However, no illnesses or injuries have been reported, making the hazard theoretical rather than confirmed.
Plain-English summary
Medline Industries is recalling multiple convenience kits that contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. The recalled kits include central line kits, small wound trays, radiology utility trays, blood culture sets, laceration trays in multiple configurations, and other clinical and surgical procedure kits.
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health in clinical and surgical settings where the kits are used for procedures such as wound care, laceration repair, and other medical interventions.
The recall affects kits distributed worldwide. Healthcare facilities and providers using affected convenience kit pack numbers and lot numbers should immediately discontinue use and contact Medline Industries for instructions on return, replacement, or disposal of affected products.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) L
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leakage
- syringe-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)
- CDS930092U
- Lot Number 19ABG536
- Lot Number 19BBK958
- Lot Number 19CBW838
- Lot Number 19EBW656
- Lot Number 19GBQ822
- Lot Number 19IBD005
- Lot Number 19VBC035
- Lot Number 20ABF408
- Lot Number 20BBN475
- Lot Number 20CBW941
- Lot Number 20EBD309
- Lot Number 20FBC457
- Lot Number 20GBQ330
- Lot Number 20HBQ731
- Lot Number 20IBM524
- Lot Number 20LBC008
- DYNDA1822
- Lot Number 21JBI823
- DYNDA2865
Distribution
Distribution scope not specified by the agency.
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