MARS Monitor
GAMBRO AB · Model 800437 · UDI-DI 37332414106936
10
510(k) clearances
50
Adverse events (1 deaths)
7
Recalls
11
Facilities
Description
The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin.
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.