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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96646

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 11, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Nipro Renal Soultions USA, Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-1730-2025
Recall number
Z-1730-2025
Initiated
April 11, 2025
Classification
Class I
Status
Ongoing
Quantity
816,840 units (BC+201), 39,228 units (BC+100)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the presence of visible foreign matter.

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.

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.