Cook recalls StoneBreaker Sterilization Caps due to potential failure to achieve proper sterility levels during reprocessing. Affected units may not meet safety standards for medical use.
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 Sterilization Caps because they might not sterilize properly when following instructions. This could lead to infections in medical procedures if used without adequate sterility.
The caps may not reach the required sterility level when processed according to the manufacturer's instructions. This means medical devices could become contaminated, increasing infection risks during procedures.
Healthcare facilities using the StoneBreaker Sterilization Caps for medical device reprocessing are most at risk. Patients undergoing procedures with improperly sterilized equipment could face infection risks.
Check for the catalog number SBA-SC, GPN G52602, or UDI (01)00827002526020 on the product. All lots of this cap are affected.
Identify the catalog number SBA-SC, GPN G52602, or UDI (01)00827002526020 on the cap.
Yes, all lots of the StoneBreaker Sterilization Cap with catalog number SBA-SC, GPN G52602, and UDI (01)00827002526020 are affected.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
The recall states the caps may not achieve proper sterility, which could lead to infections, but the record does not mention risks of serious injury.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1594-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1594-2018 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.
