Cook recalls TFE Coated Curved Newton LL: Label does not state heparin coating. Affected lots include 3741882-6142463 and others. No remedy specified in recall notice.
Label does not state that the product is heparin-coated.
Cook is recalling TFE Coated Curved Newton LLT devices because the label does not state they are heparin-coated. This could mean users might not know the coating's purpose, but the recall does not specify a remedy or hazard severity.
The label not stating the product is heparin-coated could lead to confusion about its intended use. Heparin is an anticoagulant used in medical devices to prevent blood clots, so missing this information might cause improper use or treatment.
Users of the TFE Coated Curved Newton LLT devices with affected serial numbers are likely affected. Patients receiving these devices for medical use may be at risk if the heparin coating is critical for their treatment.
Check the label for the product name 'TFE Coated Curved Newton LLT' and the serial numbers listed: 3741882-6142463, F3884311-F4903643, NS5044201-NS5963180.
Look for the product name and serial numbers listed in the recall notice to confirm if your device is affected.
The recall is because the label does not state that the product is heparin-coated, which could lead to confusion about its intended use.
The recall does not specify a remedy, so there is no instruction to stop using the product.
Affected serial numbers include 3741882-6142463, F3884311-F4903643, and NS5044201-NS5963180.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-0963-2018 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.
