Medical Device Safety and Recalls: Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate

Cook Medical is recalling its central venous catheter and pressure monitoring sets and trays because the tips may split or separate from the catheters due to a manufacturing error. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.

For more information and to view the recalled products, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm493167.htm

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