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ri-integral flex flexible blade with integrated F.
Rudolf Riester GmbH · Model 12250 · UDI-DI 04045396021686
8
510(k) clearances
1,099
Adverse events (6 deaths)
11
Recalls
59
Facilities
Description
The laryngoscopes are manufactured in order to be used for endotracheal intubation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-10 | Karl Storz Endoscopy | During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2020-07-27 | Karl Storz Endoscopy | 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 |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.