Recall Z-1730-2025 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Nipro Renal Soultions USA, Corporation
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).
| Date | May 14, 2025 (initiated Apr 11, 2025) |
| Status | Open, Classified |
| Reason | Potential for the presence of visible foreign matter. |
| Root cause | Process control |
| Action | Nipro Renal notified consignees on about 04/11/2025 via "URGENT: MEDICAL DEVICE RECALL" letter dated 4/10/2025. Consignees were instructed to identify and isolate any inventory from the affected BC+201 lots, cease use of those affected lots, complete and return the Business Reply Card even if you do not have the recalled product to Nipro4621@sedgwick.com or via fax to 877-496-5036 and arrange the return of any affected lots on hand via phone 1-877-546-0126. Additionally, consignees were instructed to notify any accounts if lots were further distributed. If you have any questions, call 305- |
| Quantity | 816,840 units (BC+201), 39,228 units (BC+100) |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION Di-Chem, Inc., Jan 18, 2002 |