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House Brand Dentistry
Frontier Dental Supply Inc · Model HSB-100202 · UDI-DI 00810132808166
10
510(k) clearances
276
Adverse events (7 deaths)
6
Recalls
575
Facilities
Description
HSB - Gauze - Non-Woven, 2 x 2, N/S 4-Ply - 200 units/sleeve, 5000/Cs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-05 | Medline Industries Inc | RevMedX Trauma Dressing is being recalled due to package seal integrity. |
| 2018-12-27 | Cardinal Health 200, LLC | Curity All Purpose Sponges were not sterilized and distributed |
| 2018-10-16 | ASO, LLC | Potential that gauze pads may not be fully sterilized |
| 2015-08-12 | Revmedx Inc | The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective m |
| 2012-05-14 | Hartmann USA, Inc | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products |
| 2012-05-14 | Hartmann USA, Inc | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products |
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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.