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Medline-Microtek
Model Decanters · Microtek Medical LLC · DI 00748426139668
LHI — Set, I.V. Fluid Transfer · Class II · 21 CFR 880.5440
UDILibrary device dossier · generated 2026-09-06 · 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 (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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
5.4
2019-02
0
7.37
2019-03
0
7.28
2019-04
0
4.98
2019-05
0
4.94
2019-06
0
5.06
2019-07
0
3.51
2019-08
0
2.64
2019-09
0
3.75
2019-10
0
5.58
2019-11
0
4.54
2019-12
0
5.55
2020-01
0
5.76
2020-02
0
5.83
2020-03
0
7.11
2020-04
0
5.88
2020-05
0
6.32
2020-06
0
5.29
2020-07
0
4.58
2020-08
0
5.44
2020-09
0
7.32
2020-10
0
5.87
2020-11
0
6.3
2020-12
0
6.87
2021-01
0
6.75
2021-02
0
5.64
2021-03
0
5.3
2021-04
0
5.58
2021-05
0
7.95
2021-06
0
5.77
2021-07
0
4.85
2021-08
0
4.64
2021-09
0
3.32
2021-10
0
3.09
2021-11
0
3.14
2021-12
0
3
2022-01
0
3.58
2022-02
0
2.64
2022-03
0
4.49
2022-04
0
7.64
2022-05
0
5.66
2022-06
0
6.51
2022-07
0
4.86
2022-08
0
4.56
2022-09
0
4.86
2022-10
0
4.53
2022-11
0
5.94
2022-12
0
4.54
2023-01
0
4.96
2023-02
0
4.45
2023-03
0
6.07
2023-04
0
3.44
2023-05
0
4.22
2023-06
0
4.63
2023-07
0
4.41
2023-08
0
4.09
2023-09
0
4.37
2023-10
0
3.98
2023-11
0
5.21
2023-12
0
4.77
2024-01
0
3.16
2024-02
0
5.28
2024-03
0
5.27
2024-04
0
4.61
2024-05
0
6.46
2024-06
0
8.67
2024-07
0
8.48
2024-08
0
5.86
2024-09
0
9.2
2024-10
0
11.45
2024-11
0
9.73
2024-12
0
9
2025-01
0
5.32
2025-02
0
9.93
2025-03
0
7.59
2025-04
0
7.44
2025-05
0
5.28
2025-06
0
6.52
2025-07
0
8.12
2025-08
0
8.14
2025-09
0
6.45
2025-10
0
7.23
2025-11
0
11.05
2025-12
0
8.51
2026-01
0
10.31
2026-02
0
6.73
2026-03
0
7.27
2026-04
0
9.73
2026-05
0
6.05
2026-06
0
5.35
This device (reports/month)Average device in LHI (reports/device/month)