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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67996

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

Open FDA event record

Event summary

Timeline bucket
April 16, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gambro Renal Products, Incorporated

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

Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Z-1643-2014
Recall number
Z-1643-2014
Initiated
April 16, 2014
Classification
Class II
Status
Terminated
Quantity
2,461,824 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Code information

Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.

Distribution pattern

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

device · product 2 of 2

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Z-1644-2014
Recall number
Z-1644-2014
Initiated
April 16, 2014
Classification
Class II
Status
Terminated
Quantity
2,461,824 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Code information

Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.

Distribution pattern

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.