Arterial Line Kit 400115ARecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K780871); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 1, 2026Class IOpen, Classified

   Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

   Z-2708-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780871. One submission often covers many models, so check the product and lot details in each record.

• Z-0563-2022 · Jan 24, 2022 · Open, Classified
  1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
• Z-1936-2020 · Apr 8, 2020 · Terminated
  Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous i
• Z-1937-2020 · Apr 8, 2020 · Terminated
  Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous in
• Z-1743-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1745-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1744-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1741-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1740-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
• Z-1737-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669.
• Z-1742-2010 · Mar 29, 2010 · Terminated
  ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.