Sterilmed recalls reprocessed Agilis Steerable Introducers that may not meet endotoxin requirements per product specifications. Affected units have specific product codes and expiration dates prior to June 8, 2019.
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Sterilmed is recalling reprocessed Agilis Steerable Introducers that may not meet endotoxin standards. This could pose a risk of infection during medical procedures if used improperly.
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements as tested by LAL method. Endotoxins are bacterial components that can cause infections if introduced into the bloodstream during medical procedures.
Healthcare professionals using these devices for cardiovascular procedures are most at risk. Patients receiving procedures with the recalled devices may be affected.
Check for product codes STJ408309, STJ408310, or STJ408324 with expiration dates before June 8, 2019. These devices are used for introducing cardiovascular catheters into the heart.
Verify the product code and expiration date to confirm if the device is affected.
The reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specifications, which could lead to infection risks during medical procedures.
The affected product codes are STJ408309, STJ408310, and STJ408324 with expiration dates prior to June 8, 2019.
The recall does not require immediate discontinuation; check the product details to confirm if your device is affected.
We’ve drafted a message you can send Sterilmed to request your refund or repair — edit it as you like.
Subject: Recall Z-0090-2019 — Sterilmed Sterilmed Hello, I own a Sterilmed that is covered by recall Z-0090-2019 from Sterilmed. 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.
