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MICROTEK
Model 1 · Microtek Medical LLC · DI 00748426002535
KPE — Container, I.V. · Class II · 21 CFR 880.5025
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
2024-06-03
Z-2643-2024
Class II
Open, Classified
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
code info di
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
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
1.4
2019-03
0
4
2019-04
0
1.25
2019-05
0
1
2019-06
0
7.67
2019-07
0
2
2019-08
0
2
2019-09
0
2.17
2019-10
0
5
2019-11
0
2.5
2019-12
0
2.86
2020-01
0
2
2020-02
0
2
2020-03
0
2.43
2020-04
0
2.13
2020-05
0
1
2020-06
0
1
2020-07
0
1.25
2020-08
0
1
2020-09
0
1.25
2020-10
0
1.4
2020-11
0
1.67
2020-12
0
2
2021-01
0
1
2021-02
0
1.67
2021-03
0
2
2021-04
0
2.2
2021-05
0
1.44
2021-06
0
1.7
2021-07
0
2.56
2021-08
0
1
2021-09
0
1.33
2021-10
0
1
2021-11
0
2.6
2021-12
0
1.33
2022-01
0
2
2022-02
0
1.67
2022-03
0
2.25
2022-04
0
2.67
2022-05
1
1.5
2022-06
0
2.43
2022-07
0
1.29
2022-08
0
1
2022-09
0
1.33
2022-10
0
1.4
2022-11
0
1
2022-12
0
1.33
2023-01
0
1
2023-02
0
2.25
2023-03
0
2.44
2023-04
0
1.67
2023-05
0
1
2023-06
0
1.25
2023-07
0
1.5
2023-08
0
1
2023-09
0
2.2
2023-10
0
1
2023-11
0
1.67
2023-12
0
1
2024-01
0
1.75
2024-02
0
1.6
2024-03
0
1.5
2024-04
0
2.11
2024-05
0
1
2024-06
0
6.5
2024-07
0
3.25
2024-08
0
7.5
2024-09
0
3.57
2024-10
0
7.8
2024-11
0
1.14
2024-12
0
2.33
2025-01
0
1.44
2025-02
0
1.67
2025-03
0
7.14
2025-04
0
1.6
2025-05
0
1.13
2025-06
0
1.57
2025-07
0
1
2025-08
0
1.71
2025-09
0
1.67
2025-10
0
1
2025-11
0
3.4
2025-12
0
2.11
2026-01
0
2.17
2026-02
0
3.6
2026-03
0
2.22
2026-04
0
3.36
2026-05
0
1.71
2026-06
0
1.17
This device (reports/month)Average device in KPE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Microtek Medical LLC