Z-1730-2025 Class I Ongoing
FDA device recall Z-1730-2025 was initiated by Nipro Renal Soultions USA, Corporation on April 11, 2025 and is designated Class I. Reason for recall: Potential for the presence of visible foreign matter. The recall status is ongoing. Affected quantity: 816,840 units (BC+201), 39,228 units (BC+100).
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 816,840 units (BC+201), 39,228 units (BC+100)
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.
Distribution Pattern
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.
Code Information
a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.