—#188253

Product

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

FDA product code: FOS — Catheter, Umbilical Artery
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All lot codes

Why it was recalled

The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Cardinal Health issued Urgent Medical Device Correction letter and Acknowledgement Form on June 16, 2021 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1) REVIEW the IFU for the Safety Scalpel N11 (vendor part number 73-1811). 2) COMMUNICATE the IFU to all personnel that utilize the Argyle" UVC Insertion Tray (SKU 43201) containing Safety Scalpel N11 (vendor part number 73-1811) 3) NOTIFY any customers to whom you may have distributed/forwarded affected product or will send the product about this product correction notice and share a copy of this notice and the attached IFU. 4) POST a copy of this notification in the location where the product is stored. 5) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com whether or not you have affected product. Available Assistance: Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other customers 888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-06-16
Posted by FDA: 2021-08-13
Terminated: 2023-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.