Events

Recall of Device Recall Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve

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
    53955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0670-2010
  • Event Initiated Date
    2009-11-24
  • Event Date Posted
    2010-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87272
  • 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
    Intravascular administration set - Product Code FPA
  • Reason
    System error 9 alarms. a system error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). this alarm is generated during the pumps initiation sequence and will not allow the set to be used. this requires a new set to be obtained, thus creating a potential for delay in therapy.
  • Action
    The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.

Device

Device Recall Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure l...
  • Model / Serial
    Product code 352425. Lot number 61040398 exp 4/30/2012
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
  • Product Description
    Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

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