Gambro Renal Products, Incorporated X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Brand
Gambro Renal Products, Incorporated
Lot Codes / Batch Numbers
Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
Products Sold
Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
Gambro Renal Products, Incorporated is recalling X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 due to Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026