FDA Device recall Z-0971-2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570)
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570) by Baxter Healthcare, citing certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0971-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | DC, PR |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Reason
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Identifiers
| code_info | 700000 700001 700008 400012 700014 700015 700038 400040 400044 400057 700060 400068 700070 400073 400076 700078 700079…700000 700001 700008 400012 700014 700015 700038 400040 400044 400057 700060 400068 700070 400073 400076 700078 700079 400085 700088 700099 700105 400106 400114 700117 700131 700137 400141 700148 700180 700194 700197 400226 700227 700228 700229 700232 700236 700239 400245 700252 700254 700260 700262 700274 400282 700291 700300 700305 700306 400311 700313 700336 700347 700351 700352 400355 700356 700358 400368 700374 700376 700379 400382 700398 700400 700412 700434 700447 700465 700467 700470 400474 400480 700482 700495 700500 700517 700521 700526 700535 700544 700548 700555 700574 700585 400592 700610 400620 400621 400634 700668 700670 700671 700680 400682 700689 700691 400747 400748 400752 700757 400761 700762 700778 700802 700814 700820 400828 400844 700850 700863 700872 700883 700887 700888 700895 700901 700906 700929 700940 400948 400984 701013 401017 701021 401028 701041 401082 701084 401091 701123 701136 701176 401177 401186 401209 701210 401220 701221 701224 701232 7012 |
|---|
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-0971-2018%22
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