Z-1618-2020 Class II Terminated
FDA device recall Z-1618-2020 was initiated by Karl Storz Endoscopy on December 6, 2019 and is designated Class II. Reason for recall: 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 o… The recall status is terminated (terminated July 1, 2022). Affected quantity: 27,165 scopes.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- December 6, 2019
- Termination Date
- July 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,165 scopes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and country of Canada.
Code Information
All Lots