VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Reported: May 3, 2023 Initiated: March 22, 2023 #Z-1464-2023
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.
Details
- Recalling Firm
- Covidien LP
- Units Affected
- 51 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS. Recalled by Covidien LP. Units affected: 51 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1464-2023.
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