FDA announces recall of venous catheter product after missing instructions contribute to 2 deaths
Cardinal Health is recalling a specific model of its umbilical venous catheter insertion tray after missing safety instructions contributed to numerous complaints and two deaths.
The U.S. Food and Drug Administration sent out a Class 1 recall warning for the Argyle UVC Insertion Tray on Friday, Aug. 20. This is the FDA’s most serious type of recall, indicating use of the product can cause serious injury or death.
Umbilical catheters are most often used if a baby needs help breathing after birth, for continuous blood pressure monitoring or to deliver blood pressure medications. Once placed, clinicians, including interventional radiologists, will confirm its position via X-ray.
In this situation, the recall pertains to a scalpel component included in the UVC Insertion Tray.
“The Safety Scalpel N11 has a permanent locking feature that will not allow a clinician to unlock the scalpel once they have closed the safety shield and pushed it forward into a locked position,” the FDA said Friday. “A clinician’s inability to use the scalpel (when in the permanent locked position) poses a safety risk to the patient that could result in delayed treatment which could lead to serious injury or death.”
To date, there have been two deaths after a clinician was unable to unlock a scalpel during emergency care, along with 10 complaints.
Cardinal Health notified all affected customers on June 16 and asked organizations to complete and return a form acknowledging they received an Urgent Medical Device Correction letter.
Read the full recall here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.