Food, drugs, devices › Argon Medical Devices, Inc
Device recall: (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 04018300
Argon Medical Devices, Inc (Athens, TX) initiated this device recall on 16 Oct 2018; FDA lists 9 product records under event 83633, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 15 Jun 2021. Initiation: voluntary: firm initiated. Argon Medical Devices, Inc has 23 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Argon Medical Devices, Inc, Athens, TX.
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."
Distribution
"Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0288-2020 | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the… | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0289-2020 | Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0290-2020 | (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,… | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0291-2020 | Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0292-2020 | 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. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0293-2020 | (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf… | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0294-2020 | Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0295-2020 | Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
| Z-0296-2020 | Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. | Total number in recall for all products in dist: 49,130 units | Class II | Terminated | 13 Nov 2019 |
Context
Other enforcement events for Argon Medical Devices, Inc
All 23 events for Argon Medical Devices, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Jun 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.