MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrug
FDA device recall Z-1730-2025 · posted 2025-05-14 · Open, Classified
Recall details
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Reason for recall
- Potential for the presence of visible foreign matter.
- Action taken
- 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- 432-6699 or email: jessicao@nipromed.com. Nipro expanded the recall and notified specific international consignees on about 05/30/2025 concerning affected BC+100 lots. Customers were provided the same instructions to return all affected units and notify customers if further distributed On 06/02/2025, Nipro Renal expanded the recall again to include all BC+201 lot numbers and notified consignees via letter. The letter notified consignees that all lots were affected and instructed them to cease distribution, quarantine any on hand, complete and return the response form, and arrange for return of any lots on hand. Additionally, customers were instructed to forward the notification to customers if further distributed.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 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 Pana
- Date initiated
- 2025-04-11
- Date posted
- 2025-05-14
- Location
- Lewisberry, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION (K012547) | Di-Chem, Inc. | 2002-01-18 |