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Model IPN919549 · TELEFLEX INCORPORATED · DI 10801902188424

LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days · Class II · 21 CFR 880.5970

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2026-04-21Z-2378-2026Class IOpen, ClassifiedLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.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.

13452019-01: 0 reports for this device; peer average 3.49/device2019-02: 0 reports for this device; peer average 3.51/device2019-03: 0 reports for this device; peer average 2.8/device2019-04: 0 reports for this device; peer average 3.52/device2019-05: 0 reports for this device; peer average 3.68/device2019-06: 0 reports for this device; peer average 3.14/device2019-07: 0 reports for this device; peer average 3.77/device2019-08: 0 reports for this device; peer average 3.83/device2019-09: 0 reports for this device; peer average 3.28/device2019-10: 0 reports for this device; peer average 4.5/device2019-11: 0 reports for this device; peer average 3.51/device2019-12: 0 reports for this device; peer average 3.51/device2020-01: 0 reports for this device; peer average 4.57/device2020-02: 0 reports for this device; peer average 3.84/device2020-03: 0 reports for this device; peer average 3.56/device2020-04: 0 reports for this device; peer average 3.89/device2020-05: 0 reports for this device; peer average 4.29/device2020-06: 0 reports for this device; peer average 4.44/device2020-07: 0 reports for this device; peer average 5.25/device2020-08: 0 reports for this device; peer average 4.21/device2020-09: 0 reports for this device; peer average 3.98/device2020-10: 0 reports for this device; peer average 2.69/device2020-11: 0 reports for this device; peer average 2.28/device2020-12: 0 reports for this device; peer average 2.04/device2021-01: 0 reports for this device; peer average 2.4/device2021-02: 0 reports for this device; peer average 2.41/device2021-03: 0 reports for this device; peer average 2.88/device2021-04: 0 reports for this device; peer average 2.61/device2021-05: 0 reports for this device; peer average 2.26/device2021-06: 0 reports for this device; peer average 2.3/device2021-07: 0 reports for this device; peer average 2.76/device2021-08: 0 reports for this device; peer average 2.69/device2021-09: 0 reports for this device; peer average 3.36/device2021-10: 0 reports for this device; peer average 3.12/device2021-11: 0 reports for this device; peer average 4.02/device2021-12: 0 reports for this device; peer average 3.19/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 3.05/device2022-03: 0 reports for this device; peer average 3.41/device2022-04: 0 reports for this device; peer average 3.03/device2022-05: 0 reports for this device; peer average 2.75/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 4.86/device2022-08: 0 reports for this device; peer average 2.91/device2022-09: 0 reports for this device; peer average 3.08/device2022-10: 0 reports for this device; peer average 1.97/device2022-11: 0 reports for this device; peer average 2.77/device2022-12: 0 reports for this device; peer average 2.6/device2023-01: 0 reports for this device; peer average 3.35/device2023-02: 0 reports for this device; peer average 2.59/device2023-03: 0 reports for this device; peer average 2.22/device2023-04: 0 reports for this device; peer average 2.41/device2023-05: 0 reports for this device; peer average 2.87/device2023-06: 0 reports for this device; peer average 2.46/device2023-07: 0 reports for this device; peer average 2.95/device2023-08: 0 reports for this device; peer average 2.82/device2023-09: 0 reports for this device; peer average 2.85/device2023-10: 0 reports for this device; peer average 2.53/device2023-11: 0 reports for this device; peer average 2.11/device2023-12: 0 reports for this device; peer average 2.37/device2024-01: 0 reports for this device; peer average 2.63/device2024-02: 0 reports for this device; peer average 2.52/device2024-03: 0 reports for this device; peer average 2.32/device2024-04: 0 reports for this device; peer average 2.75/device2024-05: 0 reports for this device; peer average 2.68/device2024-06: 0 reports for this device; peer average 2.95/device2024-07: 0 reports for this device; peer average 2.41/device2024-08: 0 reports for this device; peer average 2.49/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2.46/device2024-11: 0 reports for this device; peer average 2.71/device2024-12: 0 reports for this device; peer average 2.1/device2025-01: 0 reports for this device; peer average 2.58/device2025-02: 0 reports for this device; peer average 2.14/device2025-03: 0 reports for this device; peer average 2.41/device2025-04: 0 reports for this device; peer average 1.73/device2025-05: 0 reports for this device; peer average 2.26/device2025-06: 0 reports for this device; peer average 2.08/device2025-07: 0 reports for this device; peer average 2.89/device2025-08: 0 reports for this device; peer average 2.48/device2025-09: 0 reports for this device; peer average 2.69/device2025-10: 0 reports for this device; peer average 2.46/device2025-11: 0 reports for this device; peer average 2.68/device2025-12: 0 reports for this device; peer average 2.61/device2026-01: 0 reports for this device; peer average 2.82/device2026-02: 0 reports for this device; peer average 2.75/device2026-03: 0 reports for this device; peer average 2.19/device2026-04: 0 reports for this device; peer average 2.99/device2026-05: 0 reports for this device; peer average 2.46/device2026-06: 0 reports for this device; peer average 2.96/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.49
2019-0203.51
2019-0302.8
2019-0403.52
2019-0503.68
2019-0603.14
2019-0703.77
2019-0803.83
2019-0903.28
2019-1004.5
2019-1103.51
2019-1203.51
2020-0104.57
2020-0203.84
2020-0303.56
2020-0403.89
2020-0504.29
2020-0604.44
2020-0705.25
2020-0804.21
2020-0903.98
2020-1002.69
2020-1102.28
2020-1202.04
2021-0102.4
2021-0202.41
2021-0302.88
2021-0402.61
2021-0502.26
2021-0602.3
2021-0702.76
2021-0802.69
2021-0903.36
2021-1003.12
2021-1104.02
2021-1203.19
2022-0102.36
2022-0203.05
2022-0303.41
2022-0403.03
2022-0502.75
2022-0603
2022-0704.86
2022-0802.91
2022-0903.08
2022-1001.97
2022-1102.77
2022-1202.6
2023-0103.35
2023-0202.59
2023-0302.22
2023-0402.41
2023-0502.87
2023-0602.46
2023-0702.95
2023-0802.82
2023-0902.85
2023-1002.53
2023-1102.11
2023-1202.37
2024-0102.63
2024-0202.52
2024-0302.32
2024-0402.75
2024-0502.68
2024-0602.95
2024-0702.41
2024-0802.49
2024-0902
2024-1002.46
2024-1102.71
2024-1202.1
2025-0102.58
2025-0202.14
2025-0302.41
2025-0401.73
2025-0502.26
2025-0602.08
2025-0702.89
2025-0802.48
2025-0902.69
2025-1002.46
2025-1102.68
2025-1202.61
2026-0102.82
2026-0202.75
2026-0302.19
2026-0402.99
2026-0502.46
2026-0602.96
This device (reports/month)Average device in LJS (reports/device/month)

Regulatory clearances

  • K153423 SESE 2016-01-28 (k number procode)

Predicate lineage

K153423 — cites (transitively): K132133 (d1), K103255 (d2), K081625 (d3), K093775 (d3) — cited as predicate by K161765

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — TELEFLEX INCORPORATED

  • NAI 2026-01-15 Teleflex Medical OEM LLC · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-01-26 Teleflex Medical OEM LLC · 0 citations
  • NAI 2022-12-09 Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) · 0 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • VAI 2021-07-30 Teleflex LLC (NADC) · 4 citations
  • NAI 2017-09-21 Teleflex LLC · 0 citations
  • VAI 2017-09-20 Teleflex Medical, Inc. · 1 citations
  • NAI 2017-02-02 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-08-29 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2015-08-13 Teleflex Medical Sdn. Bhd. · 0 citations
  • NAI 2015-06-05 Teleflex Medical Europe Ltd · 0 citations
  • NAI 2015-02-25 Teleflex Medical Europe, Ltd. · 0 citations
  • NAI 2014-08-28 TELEFLEX LLC · 0 citations