Ethicon recalls a specific lot of ETHIBOND EXCEL sutures (Product Code X86: PBQ797) due to potential high endotoxin levels in the raw materials used during manufacturing. This could pose a risk to patients during surgical procedures.
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Ethicon has recalled a specific lot of ETHIBOND EXCEL sutures (Product Code X865W, Lot PBQ797) because the raw materials used might have contained high levels of endotoxins. This could potentially cause adverse reactions in patients during surgery.
The suture raw materials in this specific lot may have contained high levels of endotoxins, which are bacterial components that can cause adverse reactions in patients when used during surgical procedures. Endotoxins can lead to serious complications such as fever, infection, or allergic reactions in sensitive individuals.
Surgical professionals and patients who used the recalled lot of ETHIBOND EXCEL sutures (Product Code X865W, Lot PBQ797) during procedures. Patients undergoing surgery with these sutures are at risk of potential adverse reactions.
Check for the product code X865W and lot number PBQ797 on the suture packaging. This specific lot was used for ETHIBOND EXCEL sutures intended for general soft tissue approximation and ligation in surgical procedures.
Look for the product code X865W and lot number PBQ797 on the suture packaging to confirm if it is the recalled item.
No, this recall only applies to the specific lot with product code X865W and lot number PBQ797.
The recall states that the raw materials may have contained high endotoxin levels, which could cause adverse reactions in patients during surgery, but the exact risk level is not specified.
The recall record does not mention any remedy or replacement process.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1842-2019 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1842-2019 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.
