Print-ready dossier — use your browser's print dialog to save as PDF.
Arthromatic/Uromatic
Model 2C4006 · BAXTER INTERNATIONAL INC. · DI 00085412000985
HRX — Arthroscope · Class II · 21 CFR 888.1100
LJH — System, Irrigation, Urological · Class II · 21 CFR 876.5130
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 (3)
Initiated
Recall #
Class
Status
Reason
Link basis
2013-05-15
Z-1682-2013
Class II
Terminated
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
k number procode
2013-05-15
Z-1683-2013
Class II
Terminated
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
k number procode
2013-05-15
Z-1684-2013
Class II
Terminated
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
k number procode
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
13.19
2019-02
0
3.29
2019-03
0
3.78
2019-04
0
4.27
2019-05
0
4.18
2019-06
0
3.67
2019-07
0
3.38
2019-08
0
3.9
2019-09
0
4.55
2019-10
0
4.93
2019-11
0
4.56
2019-12
0
5.21
2020-01
0
5.18
2020-02
0
5.84
2020-03
0
5.61
2020-04
0
4.89
2020-05
0
3.51
2020-06
0
5.69
2020-07
0
6.15
2020-08
0
5.62
2020-09
0
7.33
2020-10
0
8.59
2020-11
0
5.88
2020-12
0
8.73
2021-01
0
6.22
2021-02
0
5.77
2021-03
0
7.8
2021-04
0
6.1
2021-05
0
5.51
2021-06
0
5.7
2021-07
0
4.89
2021-08
0
5.25
2021-09
0
3.47
2021-10
0
5.1
2021-11
0
3.78
2021-12
0
5.41
2022-01
0
4.97
2022-02
0
3.68
2022-03
0
4.39
2022-04
0
4.17
2022-05
0
4.13
2022-06
0
4.35
2022-07
0
4.38
2022-08
0
4.33
2022-09
0
4.1
2022-10
0
3.98
2022-11
0
4.58
2022-12
0
4.6
2023-01
0
5.09
2023-02
0
4.25
2023-03
0
5.19
2023-04
0
4.82
2023-05
0
4.71
2023-06
0
4.43
2023-07
0
4.24
2023-08
0
4.98
2023-09
0
4.83
2023-10
0
4.36
2023-11
0
7.71
2023-12
0
8.69
2024-01
0
6.2
2024-02
0
6.38
2024-03
0
5.26
2024-04
0
5.97
2024-05
0
8.82
2024-06
0
8.63
2024-07
0
4.91
2024-08
0
4.86
2024-09
0
4.76
2024-10
0
6.15
2024-11
0
5.22
2024-12
0
7.47
2025-01
0
8.64
2025-02
0
6.11
2025-03
0
4.97
2025-04
0
5.43
2025-05
0
5.9
2025-06
0
5
2025-07
0
5.22
2025-08
0
4.31
2025-09
0
4.58
2025-10
0
5.02
2025-11
0
5.59
2025-12
0
5.94
2026-01
0
5.53
2026-02
0
5.52
2026-03
0
5.59
2026-04
0
6.82
2026-05
0
4.7
2026-06
0
4.85
This device (reports/month)Average device in HRX, LJH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — BAXTER INTERNATIONAL INC.