Cook recalls Dilator Coons Taper devices due to packaging with low seal strength that could compromise sterility. Affected units have specific part numbers and lot numbers. Consumers should contact Cook for details.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling Dilator Coons Taper devices because their packaging might not seal properly, risking contamination. This could lead to infections if the device is used without proper sterility.
The packaging may have low seal strength, meaning it doesn't meet required peel strength specifications. This could compromise the device's sterility, potentially leading to infections if the device is used without proper sterilization.
Medical professionals and patients using the Dilator Coons Taper for vascular or non-vascular procedures are affected. Those with the specific part numbers and lot numbers listed are most at risk.
Check for part numbers starting with JCD (e.g., JCD10.0-38-20- COONS) and lot numbers like 15787236. The product is used for dilating puncture sites or catheter tracts in medical procedures.
Reach out to Cook Incorporated for specific details about your product and instructions on how to handle it.
It's used for dilating puncture sites or catheter tracts for percutaneous placement of devices in vascular and non-vascular applications like veins, arteries, bile ducts, and kidneys.
Affected part numbers include JCD10.0-38-20- COONS (G03928), JCD12.0-38-20- COONS (G03929), and others as listed in the recall notice.
Check the part number and lot number on your device. Affected units have specific part numbers starting with JCD and lot numbers like 15787236.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1532-2024 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.