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

Recall Z-0177-2022 — Bivona Aire-Cuf Endotracheal Tube

U.S. FDA — Device Enforcement · United States · 2021-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0177-2022
Date of alert
2021-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
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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