Covidien recalls specific Dermalon suture models due to potential infection or vision loss from sterile barrier breaches in breather pouches during eye surgery.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Covidien is recalling certain Dermalon Monofilament Nylon Sutures because the sterile barrier in the breather pouch may breach, causing infection or vision loss during eye surgery if the suture comes into direct contact with the patient.
The sterile barrier in the breather pouch may breach, allowing contaminants to enter the surgical field. If the suture touches the patient directly, this could cause infection or vision damage during eye surgery.
Surgical teams using the recalled Dermalon sutures for ophthalmic procedures are at risk if the sterile barrier breaches during patient contact. Patients undergoing eye surgery with these sutures could face infection or vision loss.
Check for the model numbers: 88861741-11, 88861747-11, 88861749-24, 88861756-11, or 88861757-41. These sutures are blue, 6-0 or 5-0 size, 45cm or 75cm long, with specific lot numbers listed in the recall notice.
Identify the model number and lot number on the suture packaging to confirm if it's in the recalled list.
The sterile barrier in the breather pouch may breach, causing infection or vision loss if the suture contacts the patient during eye surgery.
The recall notice does not specify a remedy; check the model and lot numbers to determine if it's affected.
Yes, if the sterile barrier breaches during patient contact, it could cause infection or vision loss in eye surgery.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1172-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1172-2023 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.
