Events

Recall of Device Recall Pain Control Trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72237
  • Event Risk Class
    Class 2
  • Event Number
    Z-0150-2016
  • Event Initiated Date
    2015-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140317
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Anesthesia conduction kit - Product Code CAZ
  • Reason
    Potential discoloration of the duraprep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
  • Action
    BBMI provided written notification, dated August 27, 2015, to all customers in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. These customers include both BBMI direct end customers and BBMI direct distributors. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors shall be reminded of their responsibility in executing the recall.

Device

Device Recall Pain Control Trays
  • Model / Serial
    Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA