Mars Treatment Kit
GAMBRO AB · Model 800480 · UDI-DI 37332414106950
FLD
Prescription
1
510(k) clearances
50
Adverse events (1 deaths)
7
Recalls
11
Facilities
Description
The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing MARS therapy, with exclusive use being made of the MARS Monitor 1TC in combination with the Prisma Control Unit (produced by Gambro).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-21 | Baxter Healthcare Corporation | Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector |
| 2014-07-18 | Gambro Renal Products, Incorporated | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| 2014-07-18 | Gambro Renal Products, Incorporated | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| 2007-01-19 | Clark Research and Development Inc | Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions |
| 2007-01-19 | Clark Research and Development Inc | Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions |
| 2007-01-19 | Clark Research and Development Inc | Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions |
| 2007-01-19 | Clark Research and Development Inc | Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.