Custom Suture Packs recalled due to sterile barrier breach risk
Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation applies; sterile barrier breach poses risk of infection and vision loss during ophthalmic procedures. No illnesses or injuries are reported in the source material. Per rubric criteria, Class II without reported illness and with theoretical hazard merits High (3) severity.
Plain-English summary
Covidien, LP has recalled Custom Suture Packs (model US1638 and US1756) affecting 9,606 units distributed nationwide in the US and internationally. These surgical packs contain a breather pouch component.
The recall was issued because of a sterile barrier breach in the breather pouch. This breach may allow contamination and could result in infection or vision loss, particularly during ophthalmic (eye) procedures where the product has direct contact with the patient.
The affected lot numbers are US1638: A1K0289Y, A1K0291Y, A1K0283Y; and US1756: A2E0454Y. Healthcare providers who have received these products should stop using them and contact Covidien for further instructions. Patients who have undergone ophthalmic procedures with these products should contact their healthcare provider if they experience symptoms such as eye redness, pain, or vision changes.
The recalled product
- Product
- Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
- Manufacturer
- Covidien, LP
- Hazard
- sterile-barrier-breach
- infection-risk
- vision-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN: N/A Model Number Lot # US1638: A1K0289Y
- A1K0291Y
- US1638 A1K0283Y
- US1756: A2E0454Y
Distribution
Distributed nationwide across the United States.
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