CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Baxter Sigma Spectrum Infusion Pump with master Drug Library recalled

Baxter Healthcare is recalling Baxter Sigma Spectrum Infusion Pump with master Drug Library (, distributed nationwide in the US. The recall was initiated on 3 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 709860 735355 743891 749663 753665 757109 763909 768077 774906 776397 780931 785500 789177 791625 792667 794258 797835 798697 799183 801072 802788 803224 804175 804202 804235 804561 804988 806824 811741 812442 812989 813180 844637 844720 845844 846093 846115 858309 864606 864957 870921 872713 872941 873294 873296 873302 877416 879360 883764 885021 905402 910300 912661 914647 915558 921852 923011 923362 923483 923990 926408 926680 927374 927490 927810 927848 928705 929190 929572 929887 930694 930914 930972 931613 931745 932170 932315 932496 932601 933050 933625 933745 934174 934407 934629 934656 934684 934685 935474 935554 935636 936378 936422 937342 938176 938742 939342 939364 939571 942194 945100 962029 965017 965310 967527 982596 983087 996433 996840 997035 997317 999136 1000594 1006058 1006935 1008672 1011288 1011482 1012217 1012228 1012708 1012883 1013017 1013180 1013371 1013628 1015173 1015537 1015796 1015902 1016229 1016277 1016287 1017064 1017616 1017627

Quantity recalled444 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1664-2018
FDA event ID: 79815
Recalling firm: Baxter Healthcare, Medina, NY
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2018
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

3 Apr 2018	Recall initiated by company
4 May 2018	Classified by FDA	+31 days
16 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

Where it was distributed

US Nationwide & Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Baxter Sigma Spectrum Infusion Pump with master Drug Library ( recalled?

Yes. Baxter Healthcare recalled Baxter Sigma Spectrum Infusion Pump with master Drug Library ( on 3 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1664-2018.

Why was it recalled?

Which lots are affected?

Serial Numbers 709860 735355 743891 749663 753665 757109 763909 768077 774906 776397 780931 785500 789177 791625 792667 794258 797835 798697 799183 801072 802788 803224 804175 804202 804235 804561 804988 806824 811741 812442 812989 813180 844637 844720 845844 846093 846115 858309 864606 864957 870921 872713 872941 873294 873296 873302 877416 879360 883764 885021 905402 910300 912661 914647 915558 921852 923011 923362 923483 923990 926408 926680 927374 927490 927810 927848 928705 929190 929572 929887 930694 930914 930972 931613 931745 932170 932315 932496 932601 933050 933625 933745 934174 934407 934629 934656 934684 934685 935474 935554 935636 936378 936422 937342 938176 938742 939342 939364 939571 942194 945100 962029 965017 965310 967527 982596 983087 996433 996840 997035 997317 999136 1000594 1006058 1006935 1008672 1011288 1011482 1012217 1012228 1012708 1012883 1013017 1013180 1013371 1013628 1015173 1015537 1015796 1015902 1016229 1016277 1016287 1017064 1017616 1017627

Where was it sold?

US Nationwide & Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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