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Blood Product Questionnaire Module
BUOY SOFTWARE, LLC · Model 1 · UDI-DI 00860010651209
MMH
Prescription
0
510(k) clearances
1,034
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.