The FDA has issued a Recall for the Cardinal Health Argyle UVC Insertion Tray because it does not include specific Instructions for Use (IFU) for the Safety Scalpel N11 contained in the 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. If the clinician is not aware of this permanent locking feature, there could be a delay in the procedure due to obtaining a replacement scalpel.
The FDA identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product: Argyle UVC Insertion Tray containing Safety Scalpel N11
- Product Codes: Argyle UVC Insertion Tray (SKU 43201) and Safety Scalpel N11 (vendor part number 73-1811)
- Manufacturing Dates: August 13, 2019 to March 20, 2021, Distribution Dates: August 13, 2019 to May 21, 2021
- Devices Recalled in the United States: 7,197
The Safety Scalpel N11 is a component included in the Argyle UVC Insertion Tray. Clinicians use the scalpel in the process of inserting an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of newborns.
Critically ill newborn patients may require emergency umbilical vein catheter placement. 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.
There have been 10 complaints reported about this device issue. There were two reports of death in which the Safety Scalpel within the UVC kit locked permanently, and the clinician was unable to unlock for use during emergency UVC placement. No other injuries have been reported.