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Open, Classified

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

FDA Recall Z-0622-2024 · Posted 2024-09-30

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2023-11-22
Product Quantity252 units

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

US: Virginia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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