Becton, Dickinson and Company — Class II: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Becton, Dickinson and Company has initiated a Class II recall for several Swan-Ganz Jr Catheter models (SGPT54, SGPT64P, SGPT755P) due to manufacturing process and material changes that may cause the proximal injectate lumen hub to leak or break.
Becton, Dickinson and Company, clinical facilities utilizing pediatric/junior pulmonary artery catheters, and quality/manufacturing departments managing catheter production lines.
The defect presents risks of medication loss, blood loss, and infection, which are critical in hemodynamic monitoring. This suggests a potential failure in the validation of manufacturing process changes or material compatibility assessments, highlighting the necessity for rigorous change control protocols for fluid-path components.
Inventory should be quarantined immediately based on the specific model numbers. QA teams should review supplier quality and manufacturing change control records to ensure material substitutions do not compromise lumen integrity. Regulatory departments should confirm that field safety notices have been distributed to clinical end-users.
Class II. Reason: 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.. Product: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P. Firm: Becton, Dickinson and Company (Irvine CA United States). Status: Ongoing.
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