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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83015

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 31, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare 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

2 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 2

REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Z-1908-2019
Recall number
Z-1908-2019
Initiated
May 31, 2019
Classification
Class II
Status
Terminated
Quantity
1249272 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

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 potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Code information

UDI 07332414123055 Lot Numbers: C419105401 C419105501 C419105601 C419105701 C419105801 C419105901 C419106001 C419106101 C419106201 C419106301 C419106401 C419106501 C419106601 C419106701 C419106801 C419106901 C419107001 C419107101 C419107201 C419107301 C419107401 C419107501 C419107601 C419107701 C419107801 C419107901 C419108001 C419108101 C419108201 C419108301 C419108401 C419108501 C419108601 C419108701 C419108801 C419108901 C419109001 C419109101 C419109201 C419109301 C419109401 C419109501 C419109601 C419109801 C419110001 C419110101 C419110201 C419110301 C419110401 C419110501 C419110601 C419110701 C419110801 C419111001 C419111101 C419111301 C419111501 C419111601 C419111701

Distribution pattern

US Nationwide Distribution and Internationally to: Canada and Bermuda.

device · product 2 of 2

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Z-1909-2019
Recall number
Z-1909-2019
Initiated
May 31, 2019
Classification
Class II
Status
Terminated
Quantity
65403 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

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 potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Code information

UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301

Distribution pattern

US Nationwide Distribution and Internationally to: Canada and Bermuda.