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ELMED
ELMED INCORPORATED · Model SM36119-09 · UDI-DI 00842180164208
LRC
Prescription
10
510(k) clearances
561
Adverse events (13 deaths)
5
Recalls
220
Facilities
Description
9Fr. Baron Brochman Style Suction Cannula with Finger Suction Control, 5" Working Length Shaft, angled 90 deg. with 1mm distal Hole and Side Port Holes on Tip, Push On Hose Fitting, 9" Overall Length- Complete with Cleaning Stylet. Autoclavable Medical Grade Stainless Steel.
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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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.