Events

Recall of Device Recall Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 12

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-0708-2010
  • 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=87429
  • 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, Pressure Limited Check Valve, 3 Ultrasite I...
  • Model / Serial
    Product Code US3130. Lot numbers: 61040943 exp 2/28/2012, 61040944 exp 2/28/2012, 61044231 exp 2/28/2012, 61044235 exp 2/28/2012, 61044237 exp 2/28/2012, 61044239 exp 2/28/2012, 61044240 exp 2/28/2012, 61044241 exp 2/28/2012, 61044242 exp 2/28/2012, 61044243 exp 2/28/2012, 61044244 exp 2/28/2012, 61044245 exp 2/28/2012, 61044246 exp 2/28/2012, 61044248 exp 2/28/2012, 61044249 exp 2/28/2012, 61044250 exp 2/28/2012, 61044251 exp 2/28/2012, 61044254 exp 2/28/2012, 61044297 exp 3/31/2012, 61044298 exp 3/31/2012, 61044299 exp 3/31/2012, 61049823 exp 3/31/2012, 61049824 exp 3/31/2012, 61049825 exp 3/31/2012, 61049826 exp 3/31/2012, 61049827 exp 3/31/2012, 61049828 exp 3/31/2012, 61049829 exp 3/31/2012, 61049830 exp 3/31/2012, 61049831 exp 3/31/2012, 61049832 exp 3/31/2012, 61049833 exp 3/31/2012, 61049835 exp 3/31/2012, 61049836 exp 3/31/2012, 61049837 exp 3/31/2012, 61049838 exp 3/31/2012, 61049839 exp 3/31/2012, 61049840 exp 3/31/2012, 61049842 exp 3/31/2012, 61049844 exp 3/31/2012, 61049845 exp 3/31/2012, 61049846 exp 3/31/2012, 61049847 exp 3/31/2012, 61049848 exp 3/31/2012, 61049849 exp 3/31/2012, 61049850 exp 3/31/2012, 61049853 exp 4/30/2012, 61049854 exp 4/30/2012, 61049855 exp 4/30/2012, 61049856 exp 4/30/2012, 61049857 exp 4/30/2012, 61049858 exp 4/30/2012, 61049859 exp 4/30/2012, 61049862 exp 4/30/2012, 61049863 exp 4/30/2012, 61049864 exp 4/30/2012, 61049865 exp 4/30/2012, 61049866 exp 4/30/2012, 61049867 exp 4/30/2012, 61049868 exp 4/30/2012, 61049869 exp 4/30/2012, 61049870 exp 4/30/2012, 61049871 exp 4/30/2012, 61049873 exp 4/30/2012, 61049874 exp 4/30/2012, 61049875 exp 4/30/2012, 61049876 exp 4/30/2012, 61049877 exp 4/30/2012, 61049879 exp 4/30/2012, 61049880 exp 4/30/2012, 61049881 exp 4/30/2012, 61049882 exp 4/30/2012, 61049883 exp 4/30/2012, 61049884 exp 4/30/2012, 61049885 exp 4/30/2012, 61049886 exp 4/30/2012, 61056985 exp 4/30/2012, 61056986 exp 4/30/2012, 61056987 exp 4/30/2012, 61056989 exp 5/31/2012, 61056990 exp 5/31/2012, 61056991 exp 5/31/2012, 61056992 exp 5/31/2012, 61056993 exp 5/31/2012, 61056994 exp 5/31/2012, 61056995 exp 5/31/2012, 61056996 exp 5/31/2012, 61056997 exp 5/31/2012, 61056998 exp 5/31/2012, 61056999 exp 5/31/2012, 61057000 exp 5/31/2012, 61057001 exp 5/31/2012, 61057412 exp 5/31/2012, 61057413 exp 5/31/2012, 61057414 exp 5/31/2012, 61057415 exp 5/31/2012, 61057416 exp 5/31/2012, 61057417 exp 5/31/2012, 61057418 exp 5/31/2012, 61057419 exp 5/31/2012, 61062537 exp 5/31/2012, 61062538 exp 5/31/2012, 61062539 exp 5/31/2012, 61062540 exp 5/31/2012, 61062541 exp 5/31/2012, 61062542 exp 5/31/2012, 61062543 exp 5/31/2012, 61062544 exp 5/31/2012, 61062545 exp 5/31/2012, 61062546 exp 5/31/2012, 61062547 exp 5/31/2012, 61062548 exp 5/31/2012, 61062549 exp 5/31/2012, 61062550 exp 5/31/2012, 61062551 exp 5/31/2012, 61062553 exp 5/31/2012, 61062554 exp 5/31/2012, 61062555 exp 5/31/2012, 61062556 exp 5/31/2012, 61062557 exp 6/30/2012, 61062558 exp 6/30/2012, 61062559 exp 6/30/2012, 61062560 exp 6/30/2012, 61062561 exp 6/30/2012, 61062562 exp 6/30/2012, 61062563 exp 6/30/2012, 61062564 exp 6/30/2012, 61062565 exp 6/30/2012, 61062566 exp 6/30/2012, 61062567 exp 6/30/2012, 61062568 exp 6/30/2012, 61062569 exp 6/30/2012, 61062570 exp 6/30/2012, 61062571 exp 6/30/2012, 61062573 exp 6/30/2012, 61062575 exp 6/30/2012, 61062576 exp 6/30/2012, 61062579 exp 6/30/2012, 61062581 exp 6/30/2012, 61062582 exp 6/30/2012, 61062587 exp 6/30/2012, 61062588 exp 6/30/2012, 61062589 exp 6/30/2012, 61062590 exp 6/30/2012, 61062591 exp 6/30/2012, 61062592 exp 6/30/2012, 61062593 exp 7/31/2012, 61062594 exp 7/31/2012, 61066526 exp 7/31/2012, 61066527 exp 7/31/2012, 61066528 exp 7/31/2012, 61066529 exp 7/31/2012, 61066530 exp 7/31/2012, 61066531 exp 7/31/2012, 61066532 exp 7/31/2012, 61066533 exp 7/31/2012, 61066534 exp 7/31/2012, 61066535 exp 7/31/2012, 61066536 exp 7/31/2012, 61066537 exp 7/31/2012, 61066538 exp 7/31/2012, 61066539 exp 7/31/2012, 61066540 exp 7/31/2012, 61066541 exp 7/31/2012, 61066542 exp 7/31/2012, 61066543 exp 7/31/2012, 61066914 exp 7/31/2012, 61066917 exp 7/31/2012, 61066918 exp 7/31/2012, 61066921 exp 7/31/2012, 61066924 exp 7/31/2012, 61066926 exp 7/31/2012, 61066927 exp 7/31/2012, 61066929 exp 7/31/2012, 61068262 exp 7/31/2012, 00VL044293 exp 3/31/2012, 00VL044294 exp 3/31/2012, 00VL044295 exp 3/31/2012, and 00VL044296 exp 3/31/2012.
  • 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, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 129 in
  • 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