Reported Jun 20, 2012 · Terminated
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --…
Baxter Healthcare Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Corporation · 711 Park Ave · Medina, NY · 14103-1036
Is this the product you have?
- Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --
- Common/Classification NameInfusion Pump -- Class 2 medical device -- SIGMA LLC, Medina
- NY 14103 Product UsageThe Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug
- Lot codes and dates
- Serial numbers
- ranging from 700000 through 794213
4,060 of 4,060 codes
700000700001700002700003700004700005700006700007700010700012700013700014700017700018700020700021700022700023700024700029700030700031700032700033700034700035700037700038700039700040700041700042700043700045700046700047700048700049700050700051700052700053700054700055700057700058700059700060700061700062700063700064700065700066700067700069700071700073700075700076
- Amount recalled
- 63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Baxter Healthcare Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.