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

Recall Z-1411-2021 — Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

U.S. FDA — Device Enforcement · United States · 2021-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1411-2021
Date of alert
2021-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884523000887
Reported risk: Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.