Ethicon recalls 45cm flexible tip accessory set (EVT45) distributed in US. Products labeled for outside US may have been sold here. No remedy specified in recall notice.
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Ethicon is recalling a set of 45cm flexible tips (product code EVT45) that may have been distributed in the United States despite being labeled for international use. This recall addresses potential distribution errors rather than a safety hazard.
The recall indicates that products intended for international distribution may have been sold in the United States. This distribution error could lead to improper use if the product is used outside its intended market. There is no safety hazard described in the recall notice.
Users of the Evicel Fibrin Sealant system who received this accessory set in the US may be affected. Medical professionals using the product for surgical applications are most at risk due to potential distribution errors.
Check for product code EVT45 on the accessory set. The product is labeled for distribution outside the United States but may have been sold in the US. The lot number 17-0102 is associated with this recall.
Look for product code EVT45 on the accessory set to confirm if it's recalled.
No safety hazard is described in this recall. The issue is a distribution error, not a product defect.
Products labeled for international distribution may have been sold in the United States, which is not their intended market.
The recall does not specify a remedy or action to take. No stop-use instruction is provided.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1534-2018 from Ethicon. 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.
