Cook recalls StoneBreaker Single Use Probes with specific catalog numbers due to potential failure to meet sterility standards during reprocessing. Affected units may not be properly sterilized, risking infection.
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 certain StoneBreaker Single Use Probes because they might not be sterilized correctly when following the reprocessing instructions. This could lead to infection risks if the probes are used in medical procedures.
The probes may not reach the required sterility level when reprocessed according to the manufacturer's instructions. This means they could become contaminated and cause infections during medical procedures.
Healthcare professionals using these probes for medical procedures are most at risk. Patients using the probes could face infection if the probes are not properly sterilized.
Check the catalog numbers on the probe: SBP-010500, SBP-010605, SBP-016500, SBP-016605, or SBP-020425. All lots are affected.
Verify the catalog numbers on the probe: SBP-010500, SBP-010605, SBP-016500, SBP-016605, or SBP-020425.
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.
SBP-010500, SBP-010605, SBP-016500, SBP-016605, and SBP-020425.
The recall does not specify a stop-use action; the remedy is null, so users should check if they have the affected catalog numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1596-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1596-2018 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.
