Events

Recall of 18G Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Braun,B 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
    28911
  • Event Risk Class
    Class 2
  • Event Number
    Z-1133-04
  • Event Initiated Date
    2004-04-16
  • Event Date Posted
    2004-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32784
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    Catheter separated from the hub.
  • Action
    The recalling firm issued a recall notification letter on March 19, 2004 to their direct accounts. The letter identified the problem and instructs the direct account to destroy individual units but return unopened cases to the recalling firm.

Device

18G Catheter
  • Model / Serial
    Catalog/Lot numbers, respectively:   331411/60463283; 331412/60463404; 331417/60440555; 331542/60437004; 331545/60460702; 331565/60468520; 331565/60481188; 331567/60451432; 331567/60481276; 331582/60433989; 331583/60437935; 331585/60454731; 331585/60477325; 331587/60440553; 331592/60454732; 331595/60460707; 331712/60460705; 331812/60444733; 331918/60454742; 331935/60430137; 58003/60447789 ; 580099/60452854; 580125/60480896; 58017660456867 ; 580179/60453991; 580187/60444305; 7B3013/60459863; 7B3040/60451968;   S1200600N/60425597; S1200600N/60451313 S1200600N/60435666; S1200600N/60451450
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and South America.
  • Product Description
    18G Catheter is a component in various kits.
  • Manufacturer
    Braun,B Medical Inc

Manufacturer

Braun,B Medical Inc
  • Manufacturer Address
    Braun,B Medical Inc, 901 Marcon Blvd, Allentown PA 18109-9512
  • Source
    USFDA