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

Recall Z-0753-2021 — Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may i

U.S. FDA — Device Enforcement · United States · 2020-11-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0753-2021
Date of alert
2020-11-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intersurgical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00081647202239
Reported risk: The device was assembled with the incorrect exhalation port which can cause gas leakage.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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