FDA Device recall Z-0622-2024
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- FDA Device
- Class II
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 by Deroyal Industries, citing kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0622-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-22 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | VA |
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.
Identifiers
| code_info | GTIN 00749756364065, Serial Numbers: '59716839, '59867186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Deroyal Industries
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
FDA Device · Class II · 2026-09-30 · Deroyal Industries - DeRoyal Industries Inc
FDA Device · Class II · 2026-06-10 · Deroyal Industries - DeRoyal REF 71-C5100NS Tubing, Suction, Connector
FDA Device · Class II · 2025-03-12 · Deroyal Industries - DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Device · Class II · 2025-02-26 · Deroyal Industries - DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
FDA Device · Class II · 2024-11-13 · Deroyal Industries
All Deroyal Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.