Cook Inc. recalls Fixed Core Wire Guides with heparin coating not labeled. Affected units have specific lot codes; contact for remedy.
Label does not state that the product is heparin-coated.
Cook Inc. is recalling Fixed Core Wire Guides because the product label does not state it is heparin-coated. This could lead to improper use in medical procedures where heparin coating is critical for preventing blood clots.
The heparin coating prevents blood clots during medical procedures. If the label does not state the coating, healthcare providers might use the device without knowing it lacks this critical feature, potentially causing complications.
Medical professionals using the Fixed Core Wire Guides for procedures like angioplasty or stent placement are most at risk. Patients receiving these devices may be affected if the coating is not properly identified.
Check the product label for heparin coating information. Affected units have specific lot codes listed in the recall notice, including ranges like 3730001-6164916 and F3729969-F4922979.
Look for the statement that the product is heparin-coated on the label. If it is missing, the device is affected.
The recall is because the label does not state that the product is heparin-coated, which is critical for preventing blood clots during medical procedures.
Check the label for heparin coating information. If it is missing, contact Cook Inc. for further instructions.
Yes, affected lot codes include ranges like 3730001-6164916, F3729969-F4922979, and others listed in the recall notice.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0958-2018 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-0958-2018 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.
