Home › HEMOSTASIS, LLC › PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint
PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint
HEMOSTASIS, LLC · Model 9210584 · UDI-DI 00858439001330
2
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
51
Facilities
Description
PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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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.
