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ELMED
ELMED INCORPORATED · Model 24-07-23 · UDI-DI 00842180180932
LRC
Prescription
10
510(k) clearances
557
Adverse events (13 deaths)
5
Recalls
219
Facilities
Description
RHOTON BARON 7FR., 23CM (9") SUCTION TUBE WITH FINGER CONTROL SUCTION PLATE, BULB TYPE HOSE CONNECTOR WITH .161" HOLE AND CLEANING STYLET.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2013-05-24 | Gyrus Acmi, Incorporated | lack of sterility assurance |
| 2006-01-20 | Acclarent Inc | Device sterility may be compromised as evidenced by a loss of package integrity. |
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