InjuryFJD
E-Z CHEK BLOOD LEAK TEST STRIPS
Received Sep 2, 2025
Report MW5175409 · MDR key 22930166
Device
Generic name
Detector, Leak, Blood
Manufacturer
Reprocessing Products Corporation (rpc)Product problems
- Output Problem
- Pressure Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A REGISTERED NURSE (RN) CONTACTED (B)(6) CUSTOMER SERVICE VIA EMAIL TO REPORT THAT HANSON CONNECTOR AND LINE BOTH RESULTED NEGATIVE IN PRESENCE OF FRANK BLOOD LEAK WHILE USING THE E-Z CHEK BLOOD LEAK TEST STRIPS 25/BO. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).