RegWardenFDA facility compliance records
Recall

Class II — 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 II
StatusTerminated
ReasonOne Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
ProductSPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
QuantityUSA: 56 units, Canada: 2 units
DistributionWorldwide Distribution -- USA and Canada.
Initiated2014-09-03
Classified2014-09-30
Terminated2017-03-16
Recall numberZ-2738-2014
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 II recall — Baxter Healthcare Corp. (Z-2738-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69122/

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