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BALLARD™
SUNMED, LLC · Model 12245 · UDI-DI 10889483563281
10
510(k) clearances
558
Adverse events (6 deaths)
2
Recalls
369
Facilities
Description
BALLARD™ DENTASWAB™ ORAL CARE SWAB, Individually Wrapped
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.