—#204640

Product

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: GTIN 00749756364065, Serial Numbers: '59716839, '59867186

Why it was recalled

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

Root cause (FDA determination)

Device Design

Action the firm took

DeRoyal Industries issued am URGENT FIELD CORRECTIVE ACTION notice to its sole consignee on 11/22/2023 via email. The notice explained the issue and provided instructions on the proper use of the device.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US: Virginia

Timeline

Recall initiated: 2023-11-22
Posted by FDA: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.