High FDA (Devices)·Z-2738-2014·Announced 2014-10-08

Baxter SPECTRUM Pump Recall Due to Service Technician Error

Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for intravenous fluid administration where a service error could impact patient safety, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corp. is recalling SPECTRUM Pumps, Model No. 35700BAX, which are intended for the controlled administration of intravenous fluids. The recall involves 56 units in the United States and 2 units in Canada.

The recall was initiated because one service technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the period of May 5, 2014, through June 3, 2014. The affected units are identified by specific software versions (5.02.06, 6.02.06, and 6.02.11) and a list of serial numbers provided in the official notice.

Hospitals and healthcare facilities should check their inventory for the affected serial numbers and software versions. Users should contact Baxter Healthcare Corp. for instructions on how to address the potential service error.

The recalled product

Product: SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pump
Hazard: service-error
device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Software Versions 5.02.06
6.02.06
and 6.02.11
Affected Serial Numbers: 712090
723687
723842
724966
725820
735977
751130
752124
755174
768538
771990
774743
781406
783736
784698
794466
805797

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Baxter Healthcare Corp.

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