Recall Z-3331-2018— B. Braun Medical, Inc.

Name: FDA recall Z-3331-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-20

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2018-07-20, terminated 2020-05-13. It names one FDA 510(k) clearance: K032144. Product: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-20
Terminated: 2020-05-13
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K032144 — PERIFIX CATHETER CONNECTORB.Braun Medical, Inc.·cleared 2003-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.