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.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
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.
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.
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.
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.
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.
The recall states the pouch seal may be incomplete, which could lead to loss of sterility. If the seal is incomplete, the clamps might not be sterile when used in medical procedures.
Check the model number on the label: REF 046-1-200, 046-1-300, 046-1-301, or 046-1-401. Also, verify the lot number against the specific numbers listed in the recall notice.
The recall does not specify a remedy, so contact Argon Medical Devices directly for guidance on handling the affected products.
We’ve drafted a message you can send Argon Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-0293-2020 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-0293-2020 from Argon Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
