Events

Recall of NonVented Dispensing Pin

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
    73986
  • Event Risk Class
    Class 2
  • Event Number
    Z-1907-2016
  • Event Initiated Date
    2016-04-14
  • Event Date Posted
    2016-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145829
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Reason
    Bbmi recently identified a potential for a tear in the outer blister packaging on a limited number of units. the tears have been identified in the blister package paper, where the unit label writing is located.
  • Action
    B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: PA_QualityAssurance.BBMUS_Service@bbraun.com and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.

Device

NonVented Dispensing Pin
  • Model / Serial
    Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092 Product Catalog Number: 412023 and 412027
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico
  • Product Description
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve || Product Usage: || Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
  • 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