Reported Nov 13, 2019 · Terminated
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
046-1-200 | (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, , 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx |
046-1-300 | (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, , 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx |
046-1-301 | (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, , 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx |
046-1-401 | and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, , 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. |
- Amount recalled
- Total number in recall for all products in dist: 49,130 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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