Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update
Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.
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 infection from incompletely sterilized medical devices, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling 91 units of the Flexible Intubation Fiberscope (Part: 11301AA1) with Instruction Manual Version 08/2018. The recall is being conducted to provide updated sterilization instructions to healthcare facilities. The devices 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 classifies this as a Class II recall. The hazard is that incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Healthcare providers and facilities should stop using the affected devices and refer to the updated instructions provided by the manufacturer to ensure proper sterilization protocols are followed.
The recalled product
- Product
- Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - 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
- 91
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: 08/2018
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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