Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is the potential introduction of infectious agents into patient airways, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Karl Storz Endoscopy is recalling 2,083 units of the Flexible Intubation Video Endoscope (Part: 11301BNX) along with the associated Instruction Manual (Z18444US). The recall is being conducted to provide updated sterilization instructions for these devices, which are intended for the examination and visualization of a patient's upper airway and for aiding the placement of an endotracheal tube.
The updated instructions are necessary to ensure that a specific sterilization tray is not used and that ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. The FDA notes that incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
The affected units were distributed worldwide and nationwide in the United States, including in all 50 states, the District of Columbia, and Canada. The recall involves the Instruction Manual Version 01/2020. Healthcare facilities and users should stop using the affected endoscopes and follow the updated sterilization instructions provided by the manufacturer to ensure proper device safety.
The recalled product
- Product
- Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - 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.
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Affected units
- 2,083
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Instruction Manual Version: 01/2020
Distribution
Part of a larger recall action
This product is one of 8 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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