Covidien recalls specific laparotomy sponges that may not be properly sterilized, risking infection and tissue damage during surgery. Affected sponges have unique identifiers and were sold in certain lots.
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
Covidien is recalling laparotomy sponges that may not have been properly sterilized, increasing the risk of infection, tissue trauma, and sepsis if used in surgery. This recall affects specific product lots with unique identifiers.
The recalled sponges may not have been steam pre-treated before sterilization, meaning they could be non-sterile. If non-sterile, they might cause infection, tissue trauma, or sepsis during surgery. Additionally, these sponges lack an RF tag and may show as "CLEAR" on X-ray scans, potentially leading to missed sponges.
Surgical teams and hospitals using the recalled sponges are most at risk. Patients undergoing surgery with these sponges could face infection or tissue damage.
Check for the unique identifiers: UDI-DI 20884521700953 or 10884521700956. The affected lots are 230504KF, 220903KF, and 221102KF.
Immediately stop using any sponges with the unique identifiers 20884521700953 or 10884521700956.
The unique identifiers are UDI-DI 20884521700953 and 10884521700956.
The affected lots are 230504KF, 220903KF, and 221102KF.
If non-sterile, they could cause infection, tissue trauma, or sepsis during surgery. They may also show as "CLEAR" on X-ray scans, leading to missed sponges.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1330-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1330-2024 from Covidien. 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.
