Medline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
Medline is recalling convenience kits containing Swan-Ganz catheters with a defective proximal injectate lumen hub that may leak, break, or cause infection and blood loss.
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 a medical device with a risk of serious harm (infection, blood loss, medication loss). The source text states potential harms without documenting reported illnesses or injuries, which aligns with the High (3) criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 9,272 Medline Convenience kits that contain Swan-Ganz catheters affected by a manufacturing defect. The recalled products are distributed nationwide in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.
The Swan-Ganz catheters in these kits have failures in the blue proximal injectate lumen hub. Becton Dickinson (BD), the catheter manufacturer, has received complaints of leaks and breakage involving this component. These failures may result in leakage, lumen damage, and breakage of the catheter.
Affected product lots include DYNJ909090B (UDI-DI 10195327652432, Lots 24EBL051 and 24GBG271) and CDS982523M (UDI-DI 10195327560591, Lots 24ALA227, 24BLA369, 24CLA108, 24CLA518, 24DLA082, 24ELB053, and 24ILA112). The defect may lead to infection, medication loss, and blood loss.
Patients and healthcare providers should stop use of the affected kits immediately and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
- Manufacturer
- Medline Industries, LP
- Hazard
- catheter-defect
- infection-risk
- leakage
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePower-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Recalled Due to Lidocaine Quality Issues
FDA (Devices) · 2026-07-08
- ModerateDuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
FDA (Devices) · 2026-07-08