Boston Scientific recalls EkoSonic Kit 106cm, 12cm TZ due to possible mislabeling. Affected units include specific lot numbers and GTIN. No action is required as the product is safe but may be mislabeled.
Product may be mislabeled.
Boston Scientific is recalling EkoSonic Kit 106cm, 12cm TZ devices due to possible mislabeling. This means the product might not be correctly labeled, but it does not pose a safety risk. No action is needed as the product is safe but could be mislabeled.
The product may be mislabeled, meaning the labels on the kit might not correctly identify the components. This could lead to confusion about which parts are included or how to use them properly. However, the device itself is safe and does not pose a risk of injury.
Users of the EkoSonic Endovascular Device kit who purchased it with specific lot numbers (8035075225-8035075234) or the GTIN 858593006134. Medical professionals using this device are most at risk if mislabeled.
Check for lot numbers 8035075225 through 8035075234 or the GTIN 858593006134 on the product label. The EkoSonic Kit 106cm, 12cm TZ is packaged with both USC and IC components in sealed Tyvek pouches inside a carton.
Look for lot numbers 8035075225-8035075234 or GTIN 858593006134 on the product label.
No, the product is safe but may be mislabeled. The recall is for labeling accuracy, not safety.
No action is required as the product is safe. The recall is for labeling accuracy only.
Lot numbers 8035075225 through 8035075234.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1492-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1492-2022 from Boston Scientific. 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.
