Recall Z-1730-2025— Nipro Renal Soultions USA, Corporation

Name: FDA recall Z-1730-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Class I · Ongoing

Class I FDA medical device recall by Nipro Renal Soultions USA, Corporation, initiated 2025-04-11. It names one FDA 510(k) clearance: K012547. Product: MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).. Reason: Potential for the presence of visible foreign matter..

Recalling firm: Nipro Renal Soultions USA, Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-04-11
Firm location: Lewisberry, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K012547 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONDi-Chem, Inc.·cleared 2002-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).

Reason for recall

Potential for the presence of visible foreign matter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.