Z-0622-2024Class II

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

Name: Z-0622-2024 DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Creator: DeRoyal Industries Inc
Published: 2023-11-22
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2023-11-22 / Open, Classified / root cause: design

FDA source

DeRoyal Industries Inc began a recall of DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 on 2023-11-22. FDA classified it as Class II and gives the reason as "Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0622-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-22
Posted: 2024-09-30
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Product code: LRO General Surgery Tray
Reason for recall: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 252 units
Distribution: US: Virginia
Product codes and lots: GTIN 00749756364065, Serial Numbers: '59716839, '59867186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0622-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0622-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-03	2023-12-28

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)