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Recall Observatory FDA recall evidence

Device product

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 continuous administration of anesthetic fluids.

Z-3365-2018

July 20, 2018

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 80811
Status
Terminated
Classification
Class II
Quantity
24850
Official record key
device-enforcement:Z-3365-2018

Official wording

Reason: 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.

Code information: Batch: 61600775, 61607953, 61607952, 61607954, 61607958, 61602694, 61607955, 61607956, 61607957, 61607960, 61612147, 61611469, 61610329

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.