Argon Medical Devices recalls Septishield II 80cm pouches (REF 497302) due to potential incomplete seals causing sterility loss. Affected units sold with lot numbers 11228251 and 11229805.
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 Septishield II 80cm sterile pouches (REF 497302) because the seal might not form properly, risking contamination. This could affect medical procedures requiring sterile conditions.
The pouch seal may not form completely, allowing contaminants to enter the sterile product. This could lead to infections during medical procedures if the pouch is not properly sealed.
Healthcare providers using these pouches for medical procedures are most at risk. Patients receiving treatments in sterile environments could be affected if the pouches are used without proper sterility.
Check for the product name 'Septishield II', 80 cm size, and reference number 497302. Affected units were sold with lot numbers 11228251 or 11229805.
Verify the product name, size, reference number, and lot numbers to confirm if your item is affected.
The recall states the seal may be incomplete, which could risk sterility loss. Using affected units may lead to contamination during medical procedures.
The recall does not specify a remedy, so check the product details to confirm if it's affected. If affected, contact Argon Medical Devices for guidance.
Yes, affected units have lot numbers 11228251 or 11229805.
We’ve drafted a message you can send Argon to request your refund or repair — edit it as you like.
Subject: Recall Z-0295-2020 — Argon Argon Hello, I own a Argon that is covered by recall Z-0295-2020 from Argon. 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.
