Reported Apr 8, 2020 · Terminated
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which…
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1
- for the following REF numbers1. 8403xx series
- which includes8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series
- which includes8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC
- Product UsageVideo 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
- Lot codes and dates
- All Lots
- Amount recalled
- 27,165 scopes
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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