MalfunctionKPO
MEDICALYTE
Received Jun 3, 2025 · Event occurred Mar 13, 2025
Report 1528807-2025-00037 · MDR key 22134110
Device
Generic name
Bicarbonate Concentrate Solution For Dialysis
Manufacturer
Nipro Renal Solutions Usa CorporationModel number
BC+201Lot number
N4L024
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Additional Manufacturer Narrative
MDR REPORTABILITY DETERMINED DURING RE-EVALUATION OF COMPLAINTS UNDER CLASS 1 RECALL FOR BACTERIAL AND FUNGAL CONTAMINANTS (FDA RECALL NUMBER: Z-1730-2025).
Remedial action
- Recall