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"MedSource IV Start kit, 8"" Extension Set"
Model MS-80047 · MEDSOURCE INTERNATIONAL LLC · DI 00816703021811
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2022-05-25 | Z-1615-2022 | Class II | Open, Classified | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | code info di |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — MEDSOURCE INTERNATIONAL LLC
- NAI 2024-01-18 Medsource International LLC · 0 citations
- VAI 2017-01-06 Medsource International LLC · 3 citations