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High RiskFDAfda-Z-0293-2020STERILITY ISSUE

(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxe...

Units Affected
49,130
Recall Date
October 16, 2018
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0293-2020.

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0293-2020.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0293-2020.

Argon Medical Devices, Inc

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Argon Medical Devices, Inc Recall FAQ

Argon Medical Devices, Inc is the subject of a medical devices safety report: (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxe.... The notice was published on October 16, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 49,130 units are potentially affected.