VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Covidien LP
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Product Codes/Lot Numbers:
UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1465-2023
Related Recalls
Class I - Dangerous
Temperature probe devices lack FDA clearance.
Due to customer complaint regarding incorrect display box labeling.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.