Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1464-2023 — VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS

U.S. FDA — Device Enforcement · United States · 2023-03-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1464-2023
Date of alert
2023-03-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521784048
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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