IrriMAX recalls 12 units per case of Irrisept Wound Debridement System due to potential sterile pouch seal defect risking lack of sterility. Affected units have specific catalog and lot numbers.
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
IrriMAX is recalling 12 units per case of the Irrisept W: a wound debridement and cleansing system. The sterile pouch seal may be defective, risking a lack of sterility which could lead to infections.
The sterile pouch seal might not maintain sterility properly, potentially allowing contaminants to enter the wound dressing. This could lead to infections if the system is used without a properly sealed pouch.
Medical professionals using the Irrisept system for wound care are most at risk. Patients using this system could face infection if the seal is compromised.
Check for catalog number ISEPT-450-USA and lot numbers 19CAB939 or 19DAB431. The product expires by April 30, 2021.
Verify the catalog number (ISEPT-450-USA) and lot numbers (19CAB939 or 19DAB431) to confirm if your unit is affected.
12 units per case.
Potential defect in the sterile pouch seal that may result in a lack of sterility assurance.
The recall record does not specify a remedy, so check the product details to confirm if it's affected.
We’ve drafted a message you can send IrriMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-0191-2020 — IrriMAX IrriMAX Hello, I own a IrriMAX that is covered by recall Z-0191-2020 from IrriMAX. 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.
