Recall Z-0622-2024— DeRoyal Industries Inc

Name: FDA recall Z-0622-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-22

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2023-11-22. It names one FDA 510(k) clearance: K842648. Product: DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572. Reason: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-11-22
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.