Cook recalls StoneBreaker C02 Cartridges (SBC-10) due to potential failure to meet sterility standards during reprocessing. Affected units may not be sterile, risking infection. Contact Cook for details.
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 C02 Cartridges (SBC-10) because they might not be properly sterilized when reprocessed. This could lead to infections if used in medical procedures. The recall affects all units sold with the specified catalog number.
The cartridge may not reach the required sterility level when reprocessed according to the manufacturer's instructions. This could allow harmful bacteria to remain, increasing infection risk during medical procedures.
Healthcare professionals using the StoneBreaker C02 Cartridges for medical procedures are most at risk. Patients receiving procedures with these cartridges could be affected if the product isn't sterile.
Check for the catalog number SBC-10, GPN G52603, and UDI (01)10827002526034 on the cartridge. All lots of this product are affected.
Look for the catalog number SBC-10, GPN G52603, and UDI (01)10827002526034 on the cartridge.
The recall indicates the product may not be properly sterilized during reprocessing, so it is not safe for use without verification.
The recall record does not specify a remedy or replacement process.
The recall record does not provide specific action steps beyond checking product details.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1595-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1595-2018 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.
