Data Foundry

Medical device recalls 2014

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports — Class I medical device recall Z-0084-2015

Terminated recall by Baxter Healthcare Corp, reported 2014-11-12, distributed nationwide. Particulate matter found inside the fluid path.

Recall numberZ-0084-2015
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corp, Deerfield, IL, United States
Recall initiated2014-09-16
Classified2014-10-31
Reported by FDA2014-11-12
Terminated2017-06-21
DistributedNationwide (US)
Countries outside the USCA
Quantity94,224
Reason classesspecification failure
Lot numbersUR13D15112

Product

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.

Reason for recall

Particulate matter found inside the fluid path.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0084-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.