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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64175

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

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Event summary

Timeline bucket
October 12, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Holdings, 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

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

Z-0799-2013
Recall number
Z-0799-2013
Initiated
October 12, 2012
Classification
Class II
Status
Terminated
Quantity
560 cases, totaling 5590 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

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

There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

Code information

Lot 12BR08009

Distribution pattern

Nationwide Distribution.