Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2895-2020 — Flexible DCI Intubation Fiberscope, Part: 11302BDD2, 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.

U.S. FDA — Device Enforcement · United States · 2020-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2895-2020
Date of alert: 2020-07-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Karl Storz Endoscopy
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2895-2020 — Flexible DCI Intubation Fiberscope, Part: 11302BDD2, 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.

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