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U.S. Department of Health and Human Services

Class 1 Device Recall Argyle UVC Insertion Tray

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 Class 1 Device Recall Argyle UVC Insertion Traysee related information
Date Initiated by FirmJune 16, 2021
Date PostedAugust 13, 2021
Recall Status1 Terminated 3 on January 04, 2023
Recall NumberZ-2244-2021
Recall Event ID 88266
Product Classification Catheter, umbilical artery - Product Code FOS
ProductArgyle 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
Code Information All lot codes
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
15 Hampshire St Bldg 5
Mansfield MA 02048-1113
For Additional Information ContactCustomer Service Group
800-292-9332
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Labeling Change Control
ActionCardinal 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.
Quantity in Commerce7197 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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