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"Clean-Bor Tube 1-1/4"" x 13"""
Model 1012-13 · Vacumed · DI 00850644007817
BZO — Set, Tubing And Support, Ventilator (W Harness) · Class I · 21 CFR 868.5975
UDILibrary device dossier · generated 2026-09-13 · 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)
2019-07
0
2
2019-09
0
1
2019-12
0
2
2020-03
0
1
2020-06
0
1
2020-08
0
1
2020-11
0
1
2021-02
0
1
2021-03
0
1.25
2021-05
0
1
2021-06
0
1
2021-08
0
1
2021-11
0
3.5
2021-12
0
1.33
2022-01
0
1
2022-02
0
2
2022-03
0
4
2022-05
0
1.33
2022-06
0
1
2022-07
0
2
2022-08
0
1
2022-09
0
3.5
2022-10
0
2
2022-12
0
1.25
2023-01
0
6
2023-02
0
1
2023-04
0
2
2023-06
0
1
2023-07
0
1
2023-08
0
1
2023-09
0
1
2023-10
0
7
2023-11
0
2
2023-12
0
7
2024-01
0
1.67
2024-03
0
1
2024-05
0
1
2024-07
0
3
2024-08
0
4.5
2024-09
0
2
2024-10
0
12
2024-11
0
5.67
2024-12
0
8.5
2025-01
0
5
2025-02
0
3.67
2025-03
0
6
2025-04
0
5.67
2025-06
0
9
2025-07
0
2
2025-09
0
5
2025-10
0
10
2025-11
0
7
2025-12
0
5
2026-01
0
3.5
2026-02
0
3
2026-03
0
5.25
2026-04
0
5
2026-05
0
14.4
2026-06
0
6.33
This device (reports/month)Average device in BZO (reports/device/month)