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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83164

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

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Event summary

Timeline bucket
May 29, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Renal Therapies Group, LLC

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

Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216

Z-2151-2019
Recall number
Z-2151-2019
Initiated
May 29, 2019
Classification
Class II
Status
Terminated
Quantity
33732973 Cassettes; 18,674 Liberty Cyclers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

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Inspect official wording and provenance

Reason for recall

Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.

Code information

All lots

Distribution pattern

US Nationwide Distribution