A global recall of central venous catheters and pressure monitoring sets and trays was prompted by Cook Medical on Jan. 6, 2016, after an internal inspection of the devices. It found the catheters’ tips had the potential to fracture or separate due to a product assembling error.
This could results in adverse events, the Food and Drug Administration listed as:
- Loss of device function
- Need for medical intervention to retrieve a separated segment
- Other complications resulting from a separated tip occluding blood flow to end organs (examples include stroke, kidney injury, or damage to the intestines or limbs)
Specifically, Cook Medical is voluntarily recalling:
- Single Lumen Central Venous Catheter Sets and Trays
- Single Lumen Pressure Monitoring Sets
- Femoral Artery Pressure Monitoring Catheter Sets and Trays
- Radial Artery Pressure Monitoring Catheter Sets and Trays
These products were part of the 360 specific lots, and were distributed between April 24, 2015 and Oct. 23, 2015. For more information about the recalled lots, visit the FDA’s website HERE.