Cook recalls Chiba Biopsy Needles with potential packaging that doesn't maintain sterility, risking infection during medical procedures. Affected units include specific part numbers and lot numbers.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling Chiba Biopsy Needles that may have packaging with low seal strength, which could compromise sterility and lead to infections during medical procedures. This affects specific model numbers and lot numbers.
The packaging may not seal properly, which could allow contamination and compromise the sterility of the needles. This might lead to infections if the needles are used without proper sterility.
Medical professionals and patients who use the Chiba Biopsy Needles for aspiration biopsies are affected. Those with the specific part numbers and lot numbers listed in the recall are most at risk.
Check the product for part numbers starting with DCHN-18-10.0, DCHN-18-10.0-U, DCHN-18-15.0, DCHN-22-10.0, DCHN-22-10.0-U, DCHN-22-15.0, DCHN-22-15.0-U, or DCHN-22-20.0. Also, look for the corresponding lot numbers listed in the recall notice.
Review the part numbers and lot numbers listed in the recall to confirm if your needle is affected.
The affected part numbers include DCHN-18-10.0, DCHN-18-10.0-U, DCHN-18-15.0, DCHN-22-10.0, DCHN-22-10.0-U, DCHN-22-15.0, DCHN-22-15.0-U, and DCHN-22-20.0.
Check the product for the specific part numbers and lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Cook directly 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-1525-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1525-2024 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.
