VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr
Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.
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: This is a Class II FDA medical device recall. The source does not report any hospitalizations or patient injuries. The defect (internal metal burr) presents a theoretical risk of harm in a device used for airway positioning. Per the rubric, a risk-of-harm product without reported injuries scores 3 (High).
Plain-English summary
The VersaOne Reusable Positioning Cannula 8 mm Standard (Model RC8STS), manufactured by Covidien LP, is being recalled due to a manufacturing non-conformance affecting 145 units. The defect involves a metal shaving or burr that may be present on the inside of the device where the Cannula and Body components are welded together.
This internal defect could potentially cause harm due to the sharp metal burr contacting internal tissues. This is a Class II recall issued by the FDA.
The affected devices have been distributed worldwide, including across the United States (North Carolina) and internationally to Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, and Sweden. The recall affects units with specific serial numbers in the C21RAE, C21RAH, C21RAK, C21RAG, C21RAB, C21RAL, and C21RAM series.
Healthcare facilities and individuals who may have received these devices should verify their inventory using the provided serial numbers and the UDI-DI number 10884521784024, and contact Covidien LP regarding this recall.
The recalled product
- Product
- VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
- Manufacturer
- Covidien LP
- Hazard
- metal-burr
- tissue-damage
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 (1)
- UDI-DI: 10884521784024
Distribution
Distributed nationwide across the United States.
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