The FDA has announced a Class I recall for Ambu Inc’s King Vision Video Laryngoscope Reusable Adapter Size ½. The video adapters are being recalled because all devices from the affected lots will show a reversed image on the display, according to the FDA alert.
The device is used to examine a patient’s upper airway and aid in the placement of a tracheal tube. The video adapter connects to the display to show an image. The size ½ video adapter is primarily used in children up to age 10.
“Although the image may appear normal, the user’s actions will be reversed on the display for left and right directions. As the defect is not easily detectable, use of the affected video adapter may cause serious adverse health events, including airway trauma and decreased oxygen in your body (hypoxia). The reversed image may also extend the time to place the trachea tube which may lead to brain damage, organ failure and death.”
There have been no reports of injuries or death, the FDA noted.
Recalled product info:
- King Vision Video Laryngoscope Reusable Adapter Size ½, (KVLVA12)
- Lot Numbers: 010614, 010629, 010657, 010668, 010670, 010722
- Serial numbers: LHXXXXXXX10240, LHXXXXXXX10243, LHXXXXXXX10284, LHXXXXXXX10554, LHXXXXXXX10559, LHXXXXXXX10562, LHXXXXXXX10569, LHXXXXXXX10570, LHXXXXXXX10611, LHXXXXXXX10666
- Model Number: KVLVA12
- Manufactured Dates: April 2, 2019 to September 19, 2019
- Distribution Dates: August 2, 2019 to October 25, 2019 in AK, AL, CA, FL, IA, IL, KS, LA, MD, MN, MS, NC, NE, PA, SC, TX, WA, and WI
- Devices Recalled in the U.S.: 107
- Date Initiated by Firm: November 5, 2019
The FDA has directed all healthcare professionals to not use affected devices and to identify affected products by reviewing the product packaging for Lot Number or individual devices for Serial Number. The Serial Number is located inside the Adapter.
Consumers with questions may contact King Systems by phone at (410) 768-6464, Monday through Friday between 8:00am and 5:00pm (Eastern Time) or by emailing [email protected].