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ReddyPort
SMD Manufacturing LLC · Model RP-MKITQ4-1 · UDI-DI 00850001175210
10
510(k) clearances
577
Adverse events (6 deaths)
2
Recalls
376
Facilities
Description
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-03 | Avanos Medical, Inc. | Incorrect expiration date. |
| 2013-03-26 | Owens & Minor Distribution, Inc. | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loo |
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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.
