This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
MedicaLyte Liquid Bicarbonate Concentrate – 45x Proportioning (BC+201)
- Unique Device Identifier (UDI)/Model: 00817411022824
What to Do
On June 2, Nipro sent all affected customers an updated letter recommending the following actions:
- Do not use any MedicaLyte Liquid Bicarbonate Concentrate.
- Stop dispensing and distributing product and quarantine all lots.
- Isolate identified devices in possession.
- If the affected lots were further distributed, please forward the notification and report the consignees.
Reason for Recall
Nipro stated that they received reports of concerning visual irregularities in some product jugs. Returned units were sent to a third-party laboratory for analysis, where bacterial and fungal particles were identified.
Risks associated with the use of contaminated dialysate includes infections, treatment disruptions, sepsis, and possible death. Potential long-term health consequences include chronic infections which may cause or contribute to organ damage and a weakened immune system. If the contaminated product is used, the hemodialysis machine will need to be disinfected following the dialysis machine manufacturer’s recommendations.
Nipro has received reports of one serious injury and one death.
Device Use
Dialysate is part of a hemodialysis system that removes waste, toxins, and excess fluids from the body in patients with kidney failure.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Nipro at Nipro4621@sedgwick.com or 1-877-546-0126.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
