Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

Reason: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.

Code information: RPN/Catalog number: C-PMS-250 C-PMS-2502-15-3.5 C-PMS-2502-15-5.0 C-PMS-250-MONTES-A-092084 C-PMS-251 C-PMS-251J C-PMS-300 C-PMS-300-CHILDRENS-A-032988 C-PMS-300J C-PMS-301 C-PMS-301J C-PMS-301J-PKG C-PMS-400J Lots: 6028502 6034979 6083984 6194848 NS6014456 NS6014457 6148788 6254047 5906417 6160213 NS6064797 NS6014483 NS6175149 NS6184593 NS6187516 NS6014458 5889463 5898283 5922849 5941909 5964565 5976506 6021072 6028497 6143834 6160238 NS5933957 5828147 5941919 NS5932835 NS5932836 NS6050233 NS6072523 NS6108227 NS6130497 5803601 6034985 6075213 NS5833882 NS5892109 NS5892110 NS5919920 NS6021136 NS6054843 NS6072524 NS6075557 NS6082375 NS6108228 NS6148658 6067668

Distribution pattern: Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada