Cook recalls StoneBreaker Probe Cap (SBA-PC) due to potential failure to meet sterility standards during reprocessing. Affected units may not be sterile, risking infection in medical procedures.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Cook is recalling StoneBreaker Probe Caps because they might not be properly sterilized during reprocessing. This could lead to infections if used in medical procedures. Affected units include all lots of the product.
The caps may not reach the required sterility level when reprocessed according to the manufacturer's instructions. This means they could carry harmful bacteria or other pathogens during medical use.
Healthcare facilities using the StoneBreaker Probe Caps for medical procedures are most at risk. Patients undergoing surgery could be exposed to infection if the caps are not properly sterilized.
Check for the catalog number SBA-PC and global product number G52601 on the cap. All lots of this product are affected.
Look for the catalog number SBA-PC and global product number G52601 on the cap.
The recall indicates the product may not be properly sterilized, so it is not safe for medical use without the remedy.
Check for the catalog number SBA-PC and global product number G52601 on the cap. All lots are affected.
The recall does not specify a remedy, so contact Cook for guidance on safe handling.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1593-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1593-2018 from Cook. 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.
