Official recall notice
FDA DeviceClass IINotable
FDA Recall: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
- Recall date
- 2026-05-27
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Recommended action
What to do
183
Product description
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.