Recall Z-2896-2020— Karl Storz Endoscopy
Class II · Ongoing
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2020-07-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - 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.. Reason: 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..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-27
- Firm location
- El Segundo, CA, United States
Product description
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.