CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Argon Medical Devices Stopcocks recalled
Argon Medical Devices is recalling Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, 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-0290-2020
- 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
(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels 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?
(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A-Lot numbers 11226656 and 11228887; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A - Lot numbers 11226187, 11229619, and 11227967; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A - Lot numbers 11228888, 11230598; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A - Lot number 11228245; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A - Lot number 11232206; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590 - Lot numbers 11229800 and 11232485.
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 | Plugs, Male/Female Luer Lock Plug recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
More recalls from Argon Medical Devices
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|---|---|---|---|---|---|
| Device | CLASS II | L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled | Argon Medical Devices | Labeling Errors | 28 states |
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| 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 |
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