Events

Recall of B. Braun Blistered Omnifix L.L. Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by I-Flow Corporation.

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
    53080
  • Event Risk Class
    Class 2
  • Event Number
    Z-2250-2009
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84712
  • 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
    Piston syringes, Insulin syringes - Product Code FMF
  • Reason
    I-flow identified a b. braun syringe package that had a tear/hole in the paper portion of the primary package. used to provide an optional filling device for the easypump.
  • Action
    I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately. They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt. The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.

Device

B. Braun Blistered Omnifix L.L. Syringe
  • Model / Serial
    Lot Numers: 7B2868, 812193, 832357
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    France
  • Product Description
    B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • Manufacturer Address
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA