Covidien recalls Surgipro II monofilament sutures (model VP-421X) due to possible sterile barrier breach causing infection or vision loss during ophthalmic procedures.
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 Surgipro II monofilament polypropylene sutures (model VP-421X) because the sterile barrier pouch may breach during use, risking infection or vision loss in eye surgeries. This affects specific product models sold with certain lot numbers.
The sterile barrier pouch that protects the sutures from contamination may breach during use, especially when there is direct contact with the patient. This breach could allow pathogens to enter the surgical site, increasing the risk of infection or vision damage in eye procedures.
Healthcare professionals using these sutures for ophthalmic procedures are most at risk. Patients undergoing eye surgery with the recalled sutures could face infection or vision loss if the sterile barrier is compromised.
Check for model numbers VP-421X, VP-435-X, VP-541X, VP-542-X, VP-735-X, VP-738-X, VP-744-X, VP-745-X, VP-747-X, VP-853, VP-875-X, VP-900-X, VP-902-X, and VP-904-X on the packaging. The recall includes specific lot numbers listed in the record.
Identify the model number on the sutures packaging to see if it matches the recalled models listed in the record.
Reach out to Covidien for assistance with the recall process if you have the recalled model.
The sterile barrier pouch on these sutures may breach during use, potentially causing infection or vision loss in eye surgeries if there is direct patient contact.
The affected models include VP-421X, VP-435-X, VP-541X, VP-542-X, VP-735-X, VP-738-X, VP-744-X, VP-745-X, VP-747-X, VP-853, VP-875-X, VP-900-X, VP-902-X, and VP-904-X with specific lot numbers listed in the record.
Check the model number on the packaging to see if it matches the recalled models. Contact Covidien for further instructions.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1180-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1180-2023 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.
