FDA DeviceClass IINotable

FDA Recall: Swan-Ganz Pacing Catheter, Models: D200F7;

Date: 2026-05-27
Brand: Becton, Dickinson and Company
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

53

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