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MARS TREATMENT KIT TYPE 1116/1 - X-MARS US

GAMBRO AB · Model 800541 · UDI-DI 37332414107728

FLDKDI Prescription
1
510(k) clearances
50
Adverse events (1 deaths)
7
Recalls
11
Facilities

Description

The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy.

Recalls

DateFirmReason
2017-12-21Baxter Healthcare CorporationBaxter 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
2014-07-18Gambro Renal Products, IncorporatedGambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
2014-07-18Gambro Renal Products, IncorporatedGambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
2007-01-19Clark Research and Development IncLack of sterility assurance based on lack of sterility validation for labeled sterilization directions
2007-01-19Clark Research and Development IncLack of sterility assurance based on lack of sterility validation for labeled sterilization directions
2007-01-19Clark Research and Development IncLack of sterility assurance based on lack of sterility validation for labeled sterilization directions
2007-01-19Clark Research and Development IncLack of sterility assurance based on lack of sterility validation for labeled sterilization directions

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Data 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.