Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type, Class I. This device may cause serious injury or death if you continue to use it.

Affected Product 

• Product Names: Integrated Arterial Catheters found in Arterial Line Insertion kits, bundles, trays or insertion trays 
• Unique Device Identifier (UDI)/Item Numbers/UDI: 
  • ARTERIAL LINE INSERTION KIT, Item Number ART1185B/10653160379225
  • ARTERIAL LINE BUNDLE, Item Number ART255/10653160367598
  • ARTERIAL LINE TRAY, Item Number ART350/10653160362050
  • ARTERIAL LINE BUNDLE, Item Number ART355/10653160361817 
  • ARTERIAL LINE BUNDLE, Item Number ART355/10653160361817 
  • ARTERIAL LINE INSERTION TRAY, Item Number ART475/10653160367659
  • ARTERIAL LINE BUNDLE - OR, Item Number ART535A/10653160367604
  • ARTERIAL LINE TRAY, Item Number ART545A/10653160375135
  • ARTERIAL LINE INSERTION KIT, Item Number ART775C/10653160366102
  • ARTERIAL LINE TRAY, Item Number ART840/10653160366966
  • ARTERIAL LINE KIT, Item Number ART890B/10653160360834 
  • ARTERIAL LINE TRAY, Item Number ART600/10653160312727
  • ARTERIAL LINE TRAY, Item Number ART690/10653160318019

What to Do  

• Do not use Integrated Arterial Catheters found in Arterial Line Insertion kits, bundles, trays or insertion trays from affected item numbers and lots.

On December 31, 2024, Medline Industries, LP, sent all affected customers a Medical Device Recall letter recommending the following actions:

• Check stock immediately for affected item numbers and lot numbers.
• Quarantine all affected product. 
• Complete the response form at https://recalls.medline.com, using Recall Reference #: R-24-278-FGX1 and the recall code included in the letter. L
  • List the quantity of affected product in inventory. 
  • Complete and submit the form even if there is no affected product. 
  • Accounts will receive over-labels for affected inventory after the response form is submitted. 
• Remove the affected component before using the kit. This instruction will be included on the new label.  
• Distributors and others who have resold or transferred this product must notify those recipients of this recall. 

Reason for Recall

Medline Industries, LP, is recalling Integrated Arterial Catheters due to a manufacturing issue that caused excess material to be present on the catheter hub. If a catheter with excess material at the hub is used, that material could detach, potentially entering the  body at the place it is inserted or entering the bloodstream. 

The use of affected product may cause serious adverse health consequences, including blockage of blood vessels (embolism) and death.

There have been no reported injuries. There have been no reports of death. 

Device Use 

Medline Industries, LP, Integrated Arterial Catheters are found in Arterial Line Insertion kits, bundles, trays or insertion trays. An arterial catheter is used to continuously monitor blood pressure and take blood samples from patients.

Contact Information  

Customers in the U.S. with questions about this recall should contact Medline Industries, LP,  Recall Department at 866-359-1704 or recalls@medline.com.

Full List of Affected Devices

Medline Item Number	Lot Numbers
ART1185B	2024102590
ART255	2024082690, 2024101590
ART350	2024093090
ART355	2024081290, 2024112590
ART475	2024100790, 2024073090, 2024081590, 2024090990
ART535A	2024100890, 2024080190
ART545A	2024102890
ART600	2024101090
ART690	2024092490
ART775C	2024083090
ART840	2024082390, 2024093090
ART890B	2024100990

Additional FDA Resources

• FDA’s Enforcement Report 
  • Medline General Surgery Tray Kits
  • Medline General Surgery Tray Kits
• Medical Device Recall Database Entries
  • Class 1 Device Recall Medline General Surgery Tray
  • Class 1 Device Recall Medline General Surgery Tray

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

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.