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

Recall Z-0942-2018 — INFINITY DUAL HEMO MCable Pod

U.S. FDA — Device Enforcement · United States · 2017-10-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0942-2018
Date of alert
2017-10-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Draegar Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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