What’s the problem?
November 15, 2010 – FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.
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 initiated September 15, 2010 and includes 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 is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.
Do I have an Infusion Pump Recall Lawsuit?
The Personal Injury & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in defective medical device injury lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Medical Device Recall Case Evaluation: If you or a loved one has been injured by a product included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.