FDA Issues Class 1 Recall for Hospira GemStar Infusion System
The U.S. Food and Drug Administration has issued a Class 1 recall for Hospira’s GemStar Infusion System after reports of device malfunctions.
About the GemStar Infusion System Recall
- According to MassDevice, the recall was issued after the FDA received reports issues with the device’s pressure sensors which could result in significant harm or death.
- The FDA warns that affected systems could result in stopped or delayed therapy, the display of false warnings and failure to detect occlusions.
The recall affects any of the following models that were manufactured or had their sensors replaced after January 1, 2009:
- Model 13000
- Model 13100
- Model 13150
- Model 13086
- Model 13087
- Model 13088
- Health care providers are urged to perform proximal and distal occlusion tests.
Previous GemStar Infusion System Recalls
- Hospira’s GemStar Infusion System has been at the center of a number of previous Class 1 recalls.
- Most recent was a recall after it was determined damaged batteries could cause the device to shutoff unexpectedly.
- Class 1 recalls are reserved for situations in which there is a “reasonable probability that use of these products will cause serious adverse health consequences or death.”
Contact an Experienced Medical Device Recall Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects from the use of a recalled medical device, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.