Z-3347-2018 Class II Terminated
FDA device recall Z-3347-2018 was initiated by B. Braun Medical, Inc. on Jul 20, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 13, 2020). Affected quantity: 340.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Jul 20, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340
Product Description
CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 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 continuous administration of anesthetic fluids.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Code Information
Batch: 61602900
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3347-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026