Covidien recalls VersaOne Reusable Positioning Cannula 12mm Standard (RC12STS) due to potential metal shaving at weld point. Affected units have specific serial numbers and UDI-DI codes.
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Covidien is recalling Versa:One Reusable Positioning Cannula 12mm Standard (model RC12STS) because a manufacturing flaw could create a sharp metal shaving inside the cannula. This poses a risk of injury during medical procedures.
A manufacturing defect causes a small metal shaving (burr) to form at the weld point where the cannula and body components join. This burr could potentially cause injury if it contacts tissue during medical procedures.
Healthcare professionals using this cannula for medical procedures are most at risk. Patients receiving procedures with this cannula may also be affected.
Check for model number RC12STS on the cannula. Affected units have serial numbers starting with C21RXG0005 and UDI-DI code 10884521784062.
Verify the model number (RC12STS) and serial number (starting with C21RXG0005) on the cannula.
The recall indicates a potential risk of injury from a metal shaving, so it is not recommended for use until the recall remedy is applied.
Look for model number RC12STS and serial numbers starting with C21RXG0005 on the cannula.
The recall does not specify a remedy, so contact the manufacturer for guidance on next steps.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1465-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1465-2023 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.
