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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69181

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

Open FDA event record

Event summary

Timeline bucket
September 16, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp

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

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

Z-0084-2015
Recall number
Z-0084-2015
Initiated
September 16, 2014
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp
Quantity
94,224

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Particulate matter found inside the fluid path.

Code information

Product code: 2B8011 Lot Number: UR13D15112

Distribution pattern

Nationwide Distribution including Puerto Rico, and the country of Canada.

device · product 2 of 2

Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

Z-0085-2015
Recall number
Z-0085-2015
Initiated
September 16, 2014
Classification
Class I
Status
Terminated
Recalling firm
Baxter Healthcare Corp
Quantity
20448

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Particulate matter found inside the fluid path.

Code information

Product code 2B8013 Lot Number: UR13K14095

Distribution pattern

Nationwide Distribution including Puerto Rico, and the country of Canada.