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

Recall Z-1114-2020 — HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

U.S. FDA — Device Enforcement · United States · 2019-12-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1114-2020
Date of alert
2019-12-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
TELEFLEX MEDICAL INC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14026704659347
Reported risk: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
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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