Covidien recalls EGIA 60 curved tip surgical sutures due to missing pins causing incomplete staple formation, which may lead to bleeding, infection, or severe complications.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Covidien is recalling EGIA 60 curved tip surgical sutures because they might be missing pins that cause staples to form incorrectly. This can lead to bleeding, infections, or serious complications like peritonitis or pneumothorax.
The sutures may be missing one of two pins that keep the device jaws aligned. Without these pins, staples don't form properly, which can cause bleeding, infections, or severe complications like peritonitis or pneumothorax.
Surgical patients and medical professionals using the EGIA 60 curved tip sutures for procedures. Those with the specific model numbers N8L0311KY or N8M0063KY are most at risk.
Check for the model numbers N8L0311KY or N8M0063KY on the packaging or device. The product is sold under the brand name EGIA 60 CURVED TIP ART MED THICK SULU.
Inspect the suture device for missing pins that maintain jaw alignment. If pins are missing, stop using it immediately.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax.
The affected model numbers are N8L0311KY and N8M0063KY.
Check for the model numbers N8L0311KY or N8M0063KY on the packaging or device. The product is sold under the brand name EGIA 60 CURVED TIP ART MED THICK SULU.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1830-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1830-2019 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.
