VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 11mm Standard, Model Number RC11STS

Product Codes/Lot Numbers:

UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1464-2023

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