Cook Inc. recalls StoneBreaker Exhaust Line (SBA-EL) due to potential inadequate sterilization during reprocessing, which may not meet sterility standards. Affected units include all lots with specific catalog and GPN numbers.
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 Inc. is recalling its StoneBreaker Exhaust Line product because it may not be properly sterilized during reprocessing, which could lead to contamination risks. This recall affects healthcare facilities using the product for surgical procedures.
The product may not reach the required sterility level when following the manufacturer's reprocessing instructions. This could allow harmful microorganisms to remain, potentially causing infections in surgical patients.
Healthcare facilities that use the StoneBreaker Exhaust Line for surgical procedures are most at risk. The recall applies to all units with the specified catalog and GPN numbers.
Check for the catalog number SBA-EL and GPN G52600 on the product. All lots of this item are affected, so no specific date or batch range is needed.
Verify the catalog number SBA-EL and GPN G52600 on the product to confirm it is affected.
The recall indicates a potential risk of inadequate sterilization, so it is not recommended for use until the recall is addressed.
Check the product for the catalog number SBA-EL and GPN G52600. If it matches, stop using it and contact Cook Inc. for further instructions.
All lots of this product are affected; there is no specific date or batch range.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1592-2018 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-1592-2018 from Cook Inc.. 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.
