FDA MedWatch - Argyle UVC Insertion Tray by Cardinal Health: Class I Recall

Due to Missing Instructions for Use for the Safety Scalpel N11

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Argyle UVC Insertion Tray by Cardinal Health: Class I Recall - Due to Missing Instructions for Use for the Safety Scalpel N11 AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: 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. 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 Umbilical Venous Catheter (UVC) placement. No other injuries have been reported. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Safety Scalpel N11 is a component included in the Argyle UVC Insertion Tray. Clinicians use the scalpel in the process of inserting an UVC into the umbilical artery or vein of newborns. RECOMMENDATIONS: 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.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA