Cordis recalls cardiac catheter sets with non-sterile product labeled as sterile. Affected units include specific model and lot numbers. No remedy details provided in recall notice.
Non-sterile product labeled as sterile was distributed.
Cordis is recalling cardiac catheterization sets that were labeled as sterile but were actually non-sterile. This could lead to infections or other health risks if used in medical procedures.
The catheters were distributed as sterile but were non-sterile. Using non-sterile medical devices during procedures can introduce infections into the patient's body, leading to serious health complications.
Healthcare professionals using the recalled cardiac catheters for procedures are most at risk. Patients undergoing these procedures with the affected catheters could face infection risks.
Check for the model name 'Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F' and lot number 18223410. The product has a unique identifier 10705032025935.
Identify the model and lot number to confirm if your catheter is affected.
The product was labeled as sterile but was actually non-sterile, which could lead to infections during medical procedures.
The recall notice does not specify a remedy, so contact Cordis for further instructions.
Check for the model name 'Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F' and lot number 18223410.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0286-2024 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0286-2024 from Cordis. 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.
