DeRoyal Industries Inc DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Brand
DeRoyal Industries Inc
Lot Codes / Batch Numbers
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Products Sold
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
DeRoyal Industries Inc is recalling DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 due to Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards L. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026