Device recall: Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --…
Class I FDA enforcement event 61355. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Baxter Healthcare Corporation started this device recall on 6 Jul 2011. The firm address in the FDA record is in Medina, NY. FDA put the recall in Class I. FDA event 61355 has 1 product record. The first FDA enforcement report date is 20 Jun 2012. The record gives the status Terminated, with the termination date 17 Oct 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa
Recalling firm
Baxter Healthcare Corporation, Medina, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1490-2012 | 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… | 63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps | Class I | Terminated | 20 Jun 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2011
- 114
- Share of these events in Class I
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report Z-1490-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 61355. https://recallregister.com/fda/i/61355/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa
- What quantity of product is in FDA event 61355?
- The FDA record gives this quantity:
63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2011 have the same class?
- 4% of the 114 device events that started in 2011 are in Class I.