Events

Recall of Device Recall Custom Spinal Anesthesia Tray

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
    74879
  • Event Risk Class
    Class 2
  • Event Number
    Z-0327-2017
  • Event Initiated Date
    2016-07-11
  • Event Date Posted
    2016-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148668
  • 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
    Tray, surgical - Product Code LRP
  • Reason
    B. braun medical inc. is voluntarily recalling specific lots of their custom spinal anesthesia tray which contains a drug component, 5% lidocaine hydrochloride and 7.5 % dextrose injection, usp that hospira inc. has recalled because the drug product does not meet the specification for color throughout shelf life.
  • Action
    The firm, B.Braun, mailed to customers a "VOLUNTARY DRUG RECALL NOTIFICATION" letter dated July 12, 2016. The letter described the product, problem and actions to be taken and to inform the customers of a drug recall issued by Hospira, Inc. The Customers were instructed to determine their current inventory of the affected lots Do not destroy any affected product), complete and return "Product Removal Acknowledgement" form via fax to: B.Braun Medical Inc., Quality Assurance department at (610) 849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two weeks of receipt, even if you have no inventory. A BBMI Customer Service Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.

Device

Device Recall Custom Spinal Anesthesia Tray
  • Model / Serial
    Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to: AL, IL, OK, MN, MA and WI.
  • Product Description
    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) || Injection of anesthetics to provide regional anesthesia
  • 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