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

Recall Z-0009-2020 — Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

U.S. FDA — Device Enforcement · United States · 2019-06-14 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0009-2020
Date of alert
2019-06-14
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
TELEFLEX-MORRISVILLE
Product category
device
Product type
Devices
Reported risk: Device vented gas below the stated pressure.
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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