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SGP (Plasma Management System)
BIOMAT USA, INC. · Model 7 · UDI-DI 00817955020010
0
510(k) clearances
1,040
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-25 | ConvaTec, Inc | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. |
| 2010-06-22 | SCC Soft Computer | SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient hi |
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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.