Events

Recall of Device Recall Diacap(R) Ultra Dialysis Fluid Filter

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
    64504
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-2013
  • Event Initiated Date
    2013-03-01
  • Event Date Posted
    2013-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116364
  • 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
    System, dialysate delivery, central multiple patient - Product Code FKQ
  • Reason
    There is the potential of the residual moisture of the diacap ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
  • Action
    B. Braun Medical Inc. sent and "URGENT RECALL NOTICE" dated February 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Support Department at (800) 848-2066 for questions regarding this issue. This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113. Customers were notified via certified mail on/about June 14, 2013.

Device

Device Recall Diacap(R) Ultra Dialysis Fluid Filter
  • Model / Serial
    Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012.  This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
  • Product Description
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. || Intended to filter bacteria and endotoxins from dialysis fluid.
  • 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