FDA Device recall Z-1490-2012
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pum…
- FDA Device
- Class I
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class I recall of Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pum… by Baxter Healthcare, citing 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 resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1490-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2011-07-06 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The 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.
Reason
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.
Identifiers
| code_info | Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 7000…Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700010, 700012, 700013, 700014, 700017, 700018, 700020, 700021, 700022, 700023, 700024, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700037, 700038, 700039, 700040, 700041, 700042, 700043, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700053, 700054, 700055, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700069, 700071, 700073, 700075, 700076, 700077, 700080, 700081, 700082, 700085, 700086, 700088, 700089, 700090, 700093, 700094, 700095, 700097, 700098, 700100, 700101, 700103, 700104, 700106, 700108, 700109, 700110, 700111, 700112, 700114, 700117, 700118, 700119, 700120, 700121, 700123, 700126, 700127, 700129, 700130, 700132, 700133, 700134, 700135, 700137, 700138, 700139, 700141, 700142, 700143, 700144, 700145, 700147, 700149, 700151, 700152, 700153, 700156, 700157, 700158, 700159, 700161, 700162, 700 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1490-2012%22
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