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MedSource Sharps Dart 24/case

Model MS-64250 · MEDSOURCE INTERNATIONAL LLC · DI 00816703021392

MMK — Container, Sharps · Class II · 21 CFR 880.5570

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 (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

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.

Malfunction: 1

142841552019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.25/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2.67/device2021-07: 0 reports for this device; peer average 1.67/device2021-08: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 3.33/device2022-09: 0 reports for this device; peer average 9/device2023-02: 0 reports for this device; peer average 6/device2024-01: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 55/device2026-01: 1 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 7/device0507080911120102030405070809111203040506070810090201060111120105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-0701
2019-0801.5
2019-0901
2019-1101.5
2019-1201
2020-0101
2020-0201.25
2020-0301
2020-0401
2020-0501
2020-0701
2020-0801
2020-0901
2020-1101
2020-1201
2021-0301
2021-0401
2021-0501
2021-0602.67
2021-0701.67
2021-0801
2021-1003.33
2022-0909
2023-0206
2024-0103
2024-0603
2025-0102
2025-1103
2025-12055
2026-0111
2026-0507
This device (reports/month)Average device in MMK (reports/device/month)

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