medical Class II Updated 2020-09-02

Karl Storz Endoscopy recalls Flexible DCI Intubation Fiberscope, Part: 11301BND1, with In

Recalled Product

Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.


Hazard / Issue

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Instruction Manual Version: 08/2018
View official government recall

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