Boston Scientific recalls EkoSonic Kit 135cm, 12cm TZ due to potential mislabeling. Affected units include specific lot numbers and GTIN. Consumers should check product labels for correct identification.
Product may be mislabeled.
Boston Scientific is recalling EkoSonic Endovascular Kits that may be mislabeled. This could lead to incorrect use or confusion about the product's specifications. Consumers should verify the product labels to ensure they have the correct kit.
The product may be mislabeled, meaning the labels on the kit might not correctly identify the components. This could lead to using the wrong parts during medical procedures, potentially causing errors in treatment. However, the recall does not indicate a risk of injury or serious harm in normal use.
Users of the EkoSonic Endovascular Kit 135cm, 12cm TZ who purchased it between the specified lot numbers. Medical professionals using the kit for endovascular procedures are most at risk due to potential mislabeling.
Check the product label for the lot numbers 8035075263 through 8035075272. The kit includes both USC and IC components sealed in a Tyvek pouch inside a carton with specific GTIN: 858593006264.
Look for the lot numbers 8035075263 through 8035075272 on the product label.
The EkoSonic Kit 135cm, 12cm TZ may be mislabeled, which could lead to incorrect use or confusion about the product's specifications.
Check the product label for the lot numbers 8035075263 through 8035075272. If you have the correct lot numbers, you may continue using the product as normal.
The recall states there is a potential for mislabeling, but it does not indicate a risk of injury or serious harm in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1491-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1491-2022 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.
