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SEADUC
Em Innovations Inc · Model EMI700 · UDI-DI 00860007555336
1
510(k) clearances
3,487
Adverse events (42 deaths)
89
Recalls
248
Facilities
Description
The first and only completely hand held manual suction device with the capability to perform the SALAD technique. Affordable, effective and simple to use, SEADUC™ provides instant readiness for resuscitation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
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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.
