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GDS (Grifols Donation System)
BIOMAT USA, INC. · Model 1 · UDI-DI 00817955020003
0
510(k) clearances
1,034
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), and sample management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company’s plasma donor centers.
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.