Z-2244-2021Class I

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to...

Name: Z-2244-2021 Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to...
Creator: Cardinal Health 200, LLC
Published: 2021-06-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-06-16 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of 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... on 2021-06-16. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2244-2021
Classification: Class I
Status: Terminated
Initiated: 2021-06-16
Posted: 2021-08-13
Terminated: 2023-01-04
Recalling firm: Medtronic, Inc.
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
Product code: FOS Catheter, Umbilical Artery
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 [email protected] 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: [email protected] or call 800-292-9332.
Quantity in commerce: 7197 units
Distribution: US Nationwide distribution.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2244-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2021	Class I	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-16

Product code FOS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)