Exact FDA event identifier

Event 64820

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

Open FDA event record

Event summary

Timeline bucket: March 18, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: NxStage Medical, Inc.

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

NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-1214-2013

Recall number: Z-1214-2013
Initiated: March 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: NxStage Medical, Inc.
Quantity: 1480 cases (2 bags per case)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product may be mislabeled.

Code information

F023444

Distribution pattern

Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.