Covidien recalls two custom suture packs (US1638 and US1756) due to potential infection or vision loss if sterile barrier is breached 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 two specific custom suture packs (US1638 and US1756) because their sterile pouches might get breached, causing infections or vision damage during eye surgery. This is serious for procedures where the suture pack touches the patient directly.
The sterile barrier in the suture pack's breather pouch might break, allowing contaminants to enter. If the pouch touches the patient during eye surgery, this could cause infections or vision damage.
Ophthalmic surgeons and medical staff who use these suture packs for eye procedures are most at risk. Patients undergoing surgery with these packs could face infection or vision loss if the pouch breaches.
Check for model numbers US1638 or US1756 on the suture packs. The lot numbers for US1638 are A1K0283Y, A1K0289Y, A1K0291Y and for US1756 is A2E0454Y.
Immediately stop using any recalled suture packs with model numbers US1638 or US1756.
No, these specific models have a risk of infection or vision loss if the sterile pouch breaches during eye surgery.
Look for model numbers US1638 or US1756 with specific lot numbers: US1638 has lot numbers A1K0283Y, A1K0289Y, A1K0291Y and US1756 has lot number A2E0454Y.
Immediately stop using it and contact the manufacturer 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-1182-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1182-2023 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.
