inforMED
FJKClass IILife-sustaining

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

Gastroenterology, Urology · 21 CFR 876.5820

MDR events8,011All time
Recalls35All time
Registered firms135Currently listed
510(k) clearances77All time

Product problems

Reported product problem codes, most common first

Fluid/Blood Leak1,779
Air/Gas in Device1,769
Leak/Splash1,316
Incomplete or Inadequate Connection477
Replace349
Kinked341
Detachment of Device or Device Component302
Material Separation296

Trend for “Fluid/Blood Leak

050100Aug 23Feb 24Aug 24Feb 25Aug 25Feb 26

Recalls

35 recall events for this product code

See all →