MalfunctionKPO
MEDICALYTE
Received Jun 3, 2025 · Event occurred Mar 11, 2025
Report 1528807-2025-00034 · MDR key 22134108
Device
Generic name
Bicarbonate Concentrate Solution For Dialysis
Manufacturer
Nipro Renal Solutions Usa CorporationModel number
BC+201Lot number
N4K038
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
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).
Description of Event or Problem
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Remedial action
- Recall