Drug recall
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are…
FDA recall event 86009 · Class II · Karl Storz Endoscopy
Key facts
| Event ID | 86009 |
|---|---|
| Recall numbers | Z-2890-2020, Z-2891-2020, Z-2892-2020, Z-2893-2020, Z-2894-2020, Z-2895-2020, Z-2896-2020, Z-2897-2020 |
| Recalling firm | Karl Storz Endoscopy |
| Product type | Devices |
| Products | 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…, 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…, 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…, Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding…, Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding… and 3 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 27, 2020 |
| Report date | Sep 2, 2020 |
| City | El Segundo |
| State | CA |
| Country | United States |
| FEI number | 3007475226 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: