Cook recalls Amplatz Ultra Stiff Wire Guide due to missing heparin coating label information. Affected units have specific lot codes; check your product for these codes to determine if recalled.
Label does not state that the product is heparin-coated.
Cook is recalling Amplatz Ultra Stiff Wire Guides because the product label does not state it is heparin-coated. This could lead to improper use if the heparin coating is necessary for safe medical procedures.
The device is designed to be heparin-coated to prevent blood clotting during procedures. If the label does not state this coating, medical staff might use it without knowing, potentially causing blockages or complications.
Medical professionals using the Amplatz Ultra Stiff Wire Guide for procedures may be affected. Patients using the device could be at risk if the heparin coating is needed for safe blood flow.
Check the product label for lot codes: 3730001-6164916, F3729969-F4922979, NS4928020-NS6203182, 3733552-6175191, F3729974-F4933948, NS4927345-NS6177894. The device is sold under the brand Cook.
Look for lot codes on the device label to see if they match the affected ranges listed in the recall.
The recall states the label does not state the product is heparin-coated, but it does not say the device is unsafe without coating. The hazard is about labeling, not immediate danger.
Check the lot codes on your device label against the affected ranges: 3730001-6164916, F3729969-F4922979, NS4928020-NS6203182, 3733552-6175191, F3729974-F4933948, NS4927345-NS6177894.
The recall does not require stopping use; it only requires checking the label for affected lot codes.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0950-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-0950-2018 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.
