The FDA just announced an expansion of a prior Sigma Spectrum Infusion Pump recall, it said.
According to the U.S. Food & Drug Administration (FDA), the Class 1 recall involves Sigma Spectrum Infusion Pump Model 35700. The recall has been implemented due to over-infusion. The serial numbers involved in the expanded recall now range from 700000 through 794213.
Sigma expanded its recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the following exceptions: All pumps serviced by Sigma after September 21, 2010, or remediated as part of the initial recall notification, and all pumps manufactured after November 1, 2010, are not affected by this expanded recall.
The recalled Sigma Spectrum Infusion Pumps may fail suddenly, which can lead to inaccurate flow conditions during use. These inaccurate flow conditions can range from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs and these conditions could result in serious injury or death.
The agency notified healthcare professionals of the Class 1 Sigma Spectrum Infusion Pump recall involving model 35700. The recalled pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The recall was initially initiated September 15, 2010 and included serial numbers from 706497 to 724065.
Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and mandates the return of the recalled Sigma Spectrum Infusion Pumps. Sigma has also instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow could result in serious adverse health consequences or death.
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall designation means that this recall involves a situation in which there exists a reasonable probability that the use of or exposure to the violative, recalled product will cause serious adverse health consequences or death. A Class I designation is the FDA’s most serious.
Sigma’s Customer Support can be reached, toll-free, at 1.866.482.2893, Monday through Friday, from 8:00 a.m. through 5:00 p.m., Eastern Time (ET).