Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE
- Recall date
- 2026-07-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Product description
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Affected products
UDI-DI 10198459704543 Lot 26DBB599