Cook recalls StoneBreaker Pneumatic Lithotripter (SBL-KIT1) due to potential failure to meet sterility standards during reprocessing. Affected units may not be sterile, risking infection during 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 its StoneBreaker Pneumatic Lithotripter devices because they might not be properly sterilized when following reprocessing instructions. This could lead to infections during medical procedures if the device is used without adequate sterility.
The device may not reach the required sterility level when reprocessed according to the manufacturer's instructions. This means the device could become contaminated and cause infections during medical procedures if used without proper sterilization.
Healthcare professionals using the StoneBreaker Pneumatic Lithotripter for medical procedures are most at risk. Patients using the device during surgery could be exposed to infection if the device isn't properly sterilized.
Check for the catalog number SBL-KIT1 and global product number G52604 on the device. All lots of this model are affected, so no specific batch numbers are needed.
Verify that the device has been properly sterilized following the manufacturer's instructions before use.
The device may not be properly sterilized when reprocessed, so it should not be used without confirming sterility.
All units with catalog number SBL-KIT1 and global product number G52604 are affected.
Check that the device has been properly sterilized before use. If unsure, contact Cook for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1590-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1590-2018 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.
