FDA Device recall Z-1663-2018
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump wi…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump wi… by Baxter Healthcare, citing 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 omitt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1663-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-03 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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.
Reason
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.
Identifiers
| code_info | Serial Numbers 400792 402108 718349 719336 720207 724491 724820 725718 725967 728874 728899 732513 734021…Serial Numbers 400792 402108 718349 719336 720207 724491 724820 725718 725967 728874 728899 732513 734021 734895 736505 737537 743970 745479 745645 746786 746958 749627 753240 755355 755385 757870 759563 762135 763024 765577 766622 769032 769488 778233 782558 786281 786340 786870 787341 792737 795834 796263 800153 800502 801288 802530 805121 805471 805801 806919 807211 813520 814347 814382 815314 816930 820150 820359 822492 825071 825229 825451 826055 826627 828591 828705 829397 830727 831128 831212 831302 831547 831565 832787 833304 834044 834712 835095 835382 835391 836112 836152 837841 838434 838774 839173 840083 840954 842022 842183 845112 845156 847861 847901 848231 848841 849061 849254 849944 850141 850340 851569 852394 852641 852892 853302 853382 853786 854089 855099 855122 855273 856674 856866 859951 860191 860303 862042 863777 865269 865418 865580 865720 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1663-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.