B. Braun Medical, Inc. recalls ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anest…

Recall date

July 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3391-2018

FDA classification

Class II

Brand / firm

B. Braun Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 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.