FDAFDA · Food and drugs·Recall number Z-1618-2020
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
Published April 8, 2020 · Recall initiated: December 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- Worldwide distribution - US Nationwide and country of Canada.
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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