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Recall

Class I — Baxter Healthcare Corp

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusTerminated
ReasonParticulate matter found inside the fluid path.
ProductBaxter 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.
Quantity20448
DistributionNationwide Distribution including Puerto Rico, and the country of Canada.
Initiated2014-09-16
Classified2014-10-31
Terminated2017-06-21
Recall numberZ-0085-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Baxter Healthcare Corp (Z-0085-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69181/

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