Medline Medical Convenience Kits with Defective Plastic Syringes Recalled
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. 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: FDA Class II recall of medical devices with confirmed quality defects (leaks, breakage) used in high-risk procedures. No illnesses or injuries have been reported. Meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits that contain plastic syringes affected by quality issues. The affected kits are used for venous access, dialysis insertion, dialysis procedures, myelogram, lumbar puncture, and laceration repair, and have been distributed worldwide.
The plastic syringes in these kits exhibit leaks, breakage, and other quality problems that may pose a risk to patient health. These defects could affect the proper function of the syringes during use in medical procedures.
Healthcare facilities and patients should verify whether they have any of the affected products by checking lot numbers against the recall information. If affected products are found, consult with your healthcare provider or the manufacturer regarding appropriate next steps.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- breakage
- defective-syringe
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)
- CVI4830A
- Lot Number 2022072850
- CVI4835
- Lot Number 2022061350
- Lot Number 2023111490
- Lot Number 2023112790
- DT18185
- Lot Number 23EBS508
- Lot Number 23FBU960
- Lot Number 23HBQ339
- DT22005
- Lot Number 21JBI227
- DYNDC3274
- Lot Number 2022111490
- Lot Number 2023101190
- DYNDH1531
- DYNJTS4301
- DYNJTS4306
- DYNJTS8100
- PT215
Distribution
Distribution scope not specified by the agency.
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