Anesthesia Equipment Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits

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

Affected Product

The FDA is aware that Medline has issued a letter to affected customers recommending certain Anesthesia Circuit Kits and other kits containing Anesthesia Circuits be removed from where they are used or sold. Affected devices:  

Product Description: Anesthesia Circuit Kits containing 120” anesthesia tubing

What to Do

Do not use affected product. Immediately check stock for affected lots and quarantine affected product.

On October 10, Medline sent all in initial safety notice to affected customers. On October 21, a follow-up “Urgent Medical Device Recall” notification was sent. The two communications recommended the following actions:

• Do not use affected SKUs in affected lots.
• Immediately check your stock for the affected item number(s) and the affected lot number(s). Quarantine all affected product. Upon completion of the recall actions, please destroy affected product.
• If you are a distributor or have resold or transferred this product to another company or individual, notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers’ quantities on your response form.  

Reason for Recall

Medline has received multiple complaints of anesthesia circuit leaks during leak testing and patient use due to cracks in the 120” expandable tubing, resulting in potential compromised ventilation and anesthetic delivery. Medline has discontinued distributing kits that include affected products, but your facility may have received affected kits.

Cracks and leaks in the anesthesia circuit tubing may lead to ventilation failure during procedures or the need to replace circuits before or during a procedure. Cracks and resulting leaks in the anesthesia circuit tubing may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. There is also a potential risk for volatile anesthetics escaping into the operating room environment.

As of October 31, Medline has not reported any serious injuries or deaths associated with this issue. However, the FDA has identified 7 events related to the recall issue where oxygen desaturation occurred, resulting in serious injury. While these injuries were resolved by prompt replacement of the anesthesia circuit tubing, these reports demonstrate the potential for cracked and leaking anesthesia circuit tubing to lead to serious injury if not promptly addressed.

Device Use

An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline at 866-359-1704 or recalls@medline.com.  

Additional FDA Resources  

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.