Events

Recall of Device Recall Normal Saline 10ml in 12ml Syringe

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
    39386
  • Event Risk Class
    Class 2
  • Event Number
    Z-1236-2007
  • Event Initiated Date
    2007-07-30
  • Event Date Posted
    2007-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55362
  • 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
    saline flush syringe - Product Code NGT
  • Reason
    Particulate matter in product.
  • Action
    The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.

Device

Device Recall Normal Saline 10ml in 12ml Syringe
  • Model / Serial
    Item number 531587. Lot numbers 070507SFR exp 5/09, 070523SFR exp 5/09 070529SFR exp 6/09, 070601SFR exp 6/09, 070605SFR exp 6/09, 070608SFR exp 6/09, 070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09, and 070625SFR exp 6/09.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors nationwide.
  • Product Description
    Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.
  • 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