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

CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection… — recall Z-3365-2018

U.S. FDA — Device Enforcement · United States · 2018-07-20 · Class II

As described by U.S. FDA — Device Enforcement: CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for contin

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3365-2018
Date of alert
2018-07-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B. Braun Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Barcode (EAN/GTIN)
61600775
Reported risk: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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