Argon Medical Devices Vascuclamp Recall: Risk of Sterility Loss in Surgical Clamps
Argon Medical Devices recalls specific sterile surgical clamps due to potential incomplete pouch seals, risking loss of sterility during procedures. Affected models include Small Straight, Medium Straight, Medium Angled, and Large Angled clamps with certain lot numbers.
Lower-risk recall
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Contact the company
What happened, in plain English
Argon Medical Devices is recalling specific sterile surgical clamps because the pouch seal might be incomplete, which could lead to loss of sterility. This means the clamps might not be sterile when used in medical procedures, posing a risk of infection or contamination. Read more at govinfonow.com/recall/69615-argon-medical-devices-vascuclamp-recall-risk-of-sterility-loss-in.
Source Summary by GovInfoNow · govinfonow.com/recall/69615-argon-medical-devices-vascuclamp-recall-risk-of-sterility-loss-in · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0293-2020
Cite this page
“Argon Medical Devices Vascuclamp Recall: Risk of Sterility Loss in Surgical Clamps.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69615-argon-medical-devices-vascuclamp-recall-risk-of-sterility-loss-in. Based on FDA recall #Z-0293-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2020%22&limit=1).
Why it’s dangerous
The pouch seal on the clamp might not form properly, which could allow contaminants to enter the sterile product. This loss of sterility could lead to infections during medical procedures if the clamps are used without being properly sterilized.
Who’s affected
Healthcare professionals using the recalled clamps for surgical procedures are most at risk. Patients undergoing surgery with these clamps could face infection if the product is not sterile.
How to tell if you have this one
Check for the product names: Vascuclamp, Radiopaque Vascular Clamp, with model numbers REF 046-1-200, 046-1-300, 046-1-301, or 046-1-401. Look for specific lot numbers listed in the recall notice.
- Brand
Argon Medical Devices- Category
Medical device
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
| Recall number | Product, codes & lots |
|---|---|
| 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 labels is Argon Medical Devices, Inc., Athens, TX.; (1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393. |
| 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.; Lot number 11229386 |
| 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, 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.; (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. |
| 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.; Lot number 11226919 |
| 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.; Lot numbers 11228890, 11230669, and 11231874 |
| 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 boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.; (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200 - Lot number 11230432; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300 - Lot numbers 11226690 and 11231581 (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301 - Lot number 11227669; (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401 - Lot numbers 11228371 and 11230677. |
| 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.; Lot number 11232311 |
| 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.; Lot numbers 11228251 and 11229805 |
| 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.; Lot numbers 11228902 and 11230445 |
What to do — step by step
Check Product Lot Numbers
Compare your clamp's lot number with the listed numbers: 11230432 for REF 046-1-200, 11226690 and 11231581 for REF 046-1-300, 11227669 for REF 046-1-301, and 11228371 and 11230677 for REF 046-1-401.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0293-2020 (October 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0293-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.