Reported Oct 8, 2014 · Terminated
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 25212 W. Illinois Route 120 · Round Lake, IL · 60073-9799
Is this the product you have?
- SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
- Lot codes and dates
Software Versions 5.02.066.02.06and 6.02.11
- Affected Serial Numbers
7120907236877238427249667258207359777511307521247551747685387719907747437814067837367846987944668057978089018091138124628159328421208579268586728620858637218656308734598895978902609037489126199205749205899563469573949654029666849769319775509783619839799840669841299844759859469875389934459952919960149963891013037100437710145651014962967887950671and 938428
- Amount recalled
- USA: 56 units, Canada: 2 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
One 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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