Late last year, Medline Industries, LP, announced a class I recall of multiple lots of kits, trays, and bundles containing their Integrated Arterial Catheters. According to the FDA, a manufacturing defect on the hubs of the catheters presents a serious safety risk for patients.
Health care professionals most often use arterial catheters, or A-lines, when frequent blood draws are necessary or when continuous monitoring of blood pressure is appropriate. The catheter consists of a hollow tube made of sturdy, flexible plastic that is inserted into an artery. Arterial catheters are used in both adult and pediatric populations.
Medline Industries initiated the recall on December 31, 2024, notifying customers and distributors via a Medical Device Recall letter. The recall impacts 15 products, including the company’s Arterial Line Insertion kits, bundles, trays and insertion trays. The recall applies specifically to the Integrated Arterial Catheters within the bundles, trays, and kits. The products and their lot numbers are listed below:
- Arterial Line Insertion Kit (UDI # 10653160379225; Lot # 2024102590)
- Arterial Line Bundle (UDI # 10653160367598; Lot #s 2024082690 and 2024101590)
- Arterial Line Tray (UDI # 10653160362050; Lot # 2024093090)
- Arterial Line Bundle (UDI # 10653160361817; Lot #s 2024081290 and 2024112590)
- Arterial Line Insertion Tray (UDI # 10653160367659; Lot #s 2024100790, 2024073090, 2024081590, and 2024090990)
- Arterial Line Bundle – OR (UDI # 10653160367604; Lot #s 2024100890 and 2024080190)
- Arterial Line Tray, (UDI # 10653160375135; Lot # 2024102890)
- Arterial Line Insertion Kit (UDI # 10653160366102; Lot # 2024083090)
- Arterial Line Tray (UDI # 10653160366966; Lot #s 2024082390 and 2024093090)
- Arterial Line Kit (UDI # 10653160360834; Lot # 2024100990)
- Arterial Line Tray (UDI # 10653160312727; Lot # 2024101090)
- Arterial Line Tray (UDI # 10653160318019; Lot # 2024092490)
As of late December, Medline Industries had not received any reports of illness or death connected to use of their Integrated Arterial Catheters. The company announced the recall after finding that the impacted catheters contain excess material on their hubs. The issue was caused by an error in the manufacturing process, which the company is working to resolve. Insertion of an impacted catheter could cause the excess material to enter the patient’s bloodstream. The entry of foreign matter into the bloodstream could cause a fatal blockage of blood vessels.
Medline Industries asks customers to remove and quarantine the Integrated Arterial Catheters from all bundles, trays, and kits listed above. Customers should complete and return the response form included in the Medical Device Recall letter. Customers can view and complete the form here using the reference code provided in their letter.
Anyone with questions or concerns about the recall can contact the Recall Department for Medline Industries at 866-359-1704 or by email at recalls@medline.com.
Patients and health care providers can report any new adverse health events related to Medline Industries’ Integrated Arterial Catheters through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a medical device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.