Sirtex recalls SIROS D-Vial Prep Set (product code SIR-10200) due to potential particulate matter in the D-Vial. This single-use medical device may pose a risk if used improperly.
There is a potential presence of particulate matter in the D-Vial.
Sirtex is recalling its SIROS D-Vial Prep Set (product code SIR-10200) because it may contain particulate matter in the D-Vial. This could cause issues if the device is used for medical procedures, though the risk is not described as severe.
The D-Vial may contain small particles that could enter the bloodstream during medical procedures. This could lead to complications like infections or blockages if the particles are not properly filtered.
Healthcare professionals who use the SIROS D-Vial Prep Set for medical procedures are most at risk. Patients using this device for single-use medical applications may also be affected.
Check for the product code SIR-10200 on the SIROS D-Vial Prep Set. Lot numbers 1031234, 1031225, 1031227, and 1031229 are affected.
Look for the product code SIR-10200 on the SIROS D-Vial Prep Set.
Confirm if your device has lot numbers 1031234, 1031225, 1031227, or 1031229.
The recall states there is a potential presence of particulate matter, but it does not specify if the product is unsafe to use. The manufacturer recommends checking the product code and lot numbers.
The recall does not provide specific action steps beyond checking the product code and lot numbers. Contact Sirtex Medical Limited for further guidance.
Check the product code SIR-10200 and lot numbers 1031234, 1031225, 1031227, or 1031229 to determine if your device is affected.
We’ve drafted a message you can send Sirtex to request your refund or repair — edit it as you like.
Subject: Recall Z-1275-2021 — Sirtex Sirtex Hello, I own a Sirtex that is covered by recall Z-1275-2021 from Sirtex. 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.
