Multiple anesthesia breathing kits recalled by FDA due to risk of death
The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—on multiple anesthesia breathing circuit kits, after reports of cracks in the hoses that could cause leaks in the system, leaving patients with inadequate ventilation.
The affected breathing circuits are used in hospitals and other clinical settings to deliver an oxygen mixture to patients under anesthesia or during mechanical ventilation. Any reduction in flow can result in low oxygen levels and potentially kill a patient.
While no serious injuries or deaths have been reported, due to the high risk of harm, the devices may need to be removed from care settings. However, the FDA and manufacturer Draeger are making clinicians aware of an updated set of use instructions to improve safety and reduce the risk of cracking in hose lines.
What is being recalled?
Multiple product lines from Draeger are subject to the recall, specifically parts in the anesthesia breathing kits. Below is a full breakdown.
| Part No. | Product Name | UDI-DI | Potential Affected Lots |
|---|---|---|---|
| MP00355 | VentStar Flex 220 | 04048675248996 | All Lot Numbers |
| MP02737 | Anesthesia Circuit Kit Flex 1 | 04048675389620 | All Lot Numbers |
| MP02738 | Anesthesia Circuit Kit Flex 2 | 04048675389637 | All Lot Numbers |
| MP02744 | Anesthesia Circuit Kit Flex 6 | 04048675389675 | All Lot Numbers |
| MP02752 | Anesthesia Circuit Kit Flex (P)2 | 04048675389729 | All Lot Numbers |
| MP17103 | Anesthesia Circuit Kit Flex HEPA | 04048675695660 | All Lot Numbers |
Next Steps
The first thing the FDA is asking of users is to follow updated use instructions, including performing a leak test—an inspection for any cracks or wear—before every use of these breathing circuits. The check should be repeated after stretching the hose to the required length.
Draeger and the FDA remind clinicians to use hose holders to avoid creating cracks in the hose. If there’s any sign of damage, the devices must not be used.
More details were sent to known customers in a March Urgent Medical Device Notification. Any malfunction, further damage, or issue should be reported to FDA MedWatch and Draeger customer service at (267) 664-1131.
The full FDA recall alert can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.