Recall Z-1464-2023— Covidien LP
Class II · Ongoing
Class II FDA medical device recall by Covidien LP, initiated 2023-03-22. It names one FDA 510(k) clearance: K201805. Product: VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS. Reason: 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..
- Recalling firm
- Covidien LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-22
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.