Z-1465-2023 Class II Ongoing
FDA device recall Z-1465-2023 was initiated by Covidien LP on March 22, 2023 and is designated Class II. Reason for recall: 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 welde… The recall status is ongoing. Affected quantity: 1 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- March 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Code Information
UDI-DI: 10884521784062; Serial Numbers: C21RXG0005