Assembly issue spurs FDA recall on manual resuscitators
The U.S. Food and Drug Administration (FDA) announced a recall on behalf of SunMed for a line of its manual resuscitators, due to an assembly error involving the B/V (bacterial/viral) filter. The company warns that using the devices is dangerous, and can lead to hypoxia, organ failure and death.
The affected units must be removed from care settings and supply houses to ensure patient safety. The devices subject to this recall are used on adults of all ages.
There have been no reported injuries or fatalities. However, the FDA has designated this recall as Class I—the most serious type—due to the severe complications that can result from an emergency resuscitator not functioning properly.
What is being recalled?
Certain lots of Adult Manual Resuscitators from SunMed are subject to the recall. This includes all components: the medium adult mask, bag reservoir, filter, manometer and oxygen tubing.
Unique Device Identifier (UDI) and model numbers: 0884389164822 and 40884389164823—these cover the resuscitator units and cases.
Lot and serial numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817 and 526818.
Next steps
Check all inventory for the devices listed above by matching identifying numbers. If any recalled resuscitators are found, they must be quarantined immediately. These devices cannot be safely used on any patient.
SunMed alerted known customers to the issue with the B/V filter in a May 1 letter. The company instructed anyone in possession of affected devices to document the number of recalled units on hand—and then destroy them.
For a refund, send a response form to [email protected]. If any user is in need of an immediate replacement, contact SunMed at 1-800-433-2797.
The full FDA notice should be posted near resuscitators to ensure all defective units are properly identified and destroyed. It 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.