Cook recalls Amplatz Extra Stiff Wire Guide due to missing heparin coating label. Affected units have specific lot codes; check your product for the correct label.
Label does not state that the product is heparin-coated.
Cook is recalling Amplatz Extra Stiff Wire Guide catheters because the label does not state they are heparin-coated. This could lead to improper use without the coating's anticoagulant benefits.
The product is not labeled as heparin-coated, which is a critical anticoagulant coating for preventing blood clots during medical procedures. Without this label, healthcare providers might not apply the coating correctly, increasing the risk of clotting.
Users of the Amplatz Extra Stiff Wire Guide catheter who purchased it between the listed lot codes. Patients undergoing procedures requiring this catheter are most at risk.
Check the product's lot code on the packaging. Affected units have lot codes from 3730001-6164916, F3729969-F4922979, NS4928020-NS6203182, 3733552-6175191, F3729974-F4923948, or NS4927345-NS6177894.
Look for the lot code on the packaging to determine if it is affected. Affected units have specific lot codes listed in the recall notice.
The product does not have a label stating it is heparin-coated, which is critical for preventing blood clots during medical procedures.
Affected lot codes range from 3730001-6164916, F3729969-F4922979, NS4928020-NS6203182, 3733552-6175191, F3729974-F4923948, and NS4927345-NS6177894.
No action is needed if your product's lot code is not in the affected ranges listed.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0948-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-0948-2018 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.
