CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Plugs, Male/Female Luer Lock Plug recalled by Argon Medical Devices
Argon Medical Devices is recalling Plugs, Male/Female Luer Lock Plug, distributed nationwide in the US. The recall was initiated on 16 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0292-2020
- FDA event ID
- 83633
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2018
- FDA classified
- 5 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2018 | Recall initiated by company | |
| 5 Nov 2019 | Classified by FDA | +385 days |
| 13 Nov 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Where it was distributed
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Questions about this recall
Why was it recalled?
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Which lots are affected?
Lot numbers 11228890, 11230669, and 11231874
Where was it sold?
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 83633This product is part of a recall event; the main page for the event is Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp recalled | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Tri-ject, 3 Way IV Administration Organizer without Stopcock recalled | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Argon Medical Devices Double Female LL Adapter recalled | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Double Male LL Adapter recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | AHD Luer Lock Cap recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Hemostasis Valve, 7F-9F recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Septishield II recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide | |
| CLASS II | Argon Medical Devices Stopcocks recalled | Argon Medical Devices | Sterility | Nationwide |
More recalls from Argon Medical Devices
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS II | L-Cath Midline S/L Catheter (3F) recalled by Argon Medical Devices | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS I | Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | T-Lok Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | One-Piece Introducer Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |