FDA (Devices) recall action 68788
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.
Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.
Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.