Medline Vascular CDS Kit Recalled for Expired Saline Component
Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.
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 recall involving an expired injectable component within a medical device kit. No illnesses or injuries have been reported, but an expired saline poses a potential risk of patient harm if used. The severity rating reflects this risk-of-harm scenario without reported clinical incidents.
Plain-English summary
Medline Industries Inc. is recalling the Major Vascular CDS Convenience Kit (Model #CDS981543D, Lot #19HBK745) due to a component expiration date discrepancy. The kit contains a 250 mL saline injectable (NaCl) that expired in April 2020, but the overall kit's expiration date was July 31, 2021.
The issue is that medical professionals may use this kit believing all components are viable through the kit's stated expiration date. An expired injectable saline could be ineffective or compromised by bacterial growth, potentially causing harm if administered to a patient.
The recall affects Major Vascular CDS Convenience Kits distributed nationwide throughout the United States. Healthcare facilities and medical professionals who have received affected units should stop using them immediately and contact Medline Industries for replacement units.
Patients who received saline from an affected kit should contact their healthcare provider if they have concerns about their treatment.
The recalled product
- Product
- Major Vascular CDS Convenience Kit
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Injectable Kit
- Hazard
- expired-injectable
- contamination-risk
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits recalled for defective Lidocaine Ampules
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08