FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Recall number
- Z-0622-2024
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Status
- Open, Classified
- Initiated
- 2023-11-22
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- 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
- 252 units
- Distribution
- US: Virginia
- Lot, serial or model codes
- GTIN 00749756364065, Serial Numbers: '59716839, '59867186
- 510(k) numbers
- ["K842648"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28