Recall Z-0150-2016— B. Braun Medical, Inc.

Name: FDA recall Z-0150-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-27

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2015-08-27, terminated 2016-06-29. It names one FDA 510(k) clearance: K962696. Product: Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.. Reason: Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Terminated: 2016-06-29
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K962696 — PERIFIX PEDIATRIC EPIDURAL KITB.Braun Medical, Inc.·cleared 1997-04-03

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

Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.

Reason for recall

Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.

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