FDA Device Intelligence
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Apparatus, Hemoperfusion, Sorbent

FDA product code FLD · Class 2 · Gastroenterology, Urology

5
Registered devices
50
Adverse events
7
Recalls
11
510(k) clearances

Devices with this code

MARS TREATMENT KIT TYPE 1116/1 - X-MARS US — GAMBRO ABMARS Monitor — GAMBRO ABMars Treatment Kit — GAMBRO ABAdsorba Hemoperfusion cartridge — Gambro Dialysatoren GmbHAdsorba Hemoperfusion cartridge — Gambro Dialysatoren GmbH

Recent 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 t
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.