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.
Product Name: 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, 32019 to March 20, 2021
Distribution Dates: August 13, 2019 to May 21, 2021
Devices Recalled in the United States: 7,197
Date Initiated by Firm: June 16, 2021
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.
Figure 1: Argyle UVC Insertion Tray
Figure 2: Safety Scalpel N11 – Open Position
Figure 3: Safety Scalpel N11 – Closed & Unlocked Position
Figure 4: Safety Scalpel N11 – Closed & Locked Position
Reason for Recall
Cardinal Health is recalling the 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 (Figure 4). 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.
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.
Who May be Affected
- Health care providers who use the Argyle UVC Insertion Tray containing the Safety Scalpel N11
- Patients who have procedures with the Safety Scalpel N11
What to Do
On June 16, 2021, Cardinal Health sent all affected customers an Urgent Medical Device Correction letter. The letter stated the reason for recall, included the IFU for the Safety Scalpel N11 and provided the following instructions:
- Review the IFU for the Safety Scalpel N11 that was included with the letter.
- Share the IFU with all personnel who use the Argyle UVC Insertion Tray containing the Safety Scalpel N11.
- Notify any customers who may have distributed the affected product and share a copy of the IFU.
- Post a copy of this notification in the location where the product is stored.
- Complete and return the Acknowledgement Form, included with the letter, to Cardinal Health by emailing it to GMB-FieldCorrectiveAction@cardinalhealth.com or faxing it to 614-652-9648.
Contact the Cardinal Health Customer Service group with any questions about this recall or to arrange return of any product:
- Hospitals call 800-964-5227
- Federal Government Agencies call 800-444-1166
- Distributors call 800-635-6021
- All other customers call 888-444-5440
- Medical Device Recall Database Entry
- Cardinal Health: Argyle Umbilical Catheter Insertion Trays (external link icon)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.