Events

Recall of Device Recall Crosser 14S Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Flowcardia 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
    50791
  • Event Risk Class
    Class 2
  • Event Number
    Z-0938-2011
  • Event Initiated Date
    2009-01-09
  • Event Date Posted
    2011-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77308
  • 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, percutaneous - Product Code DQY
  • Reason
    Mislabeled expiration date: some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.
  • Action
    The firm, FlowCardia, Inc., sent an "URGENT! Medical Device Recall" letter dated January 9, 2009 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to return the product to FlowCardia, at the firms expense, for replacement and Confirm that this product has been used by completing and returning the attached fax document via fax to 408-616-0053. The customers were ask to please make an attempt to contact the customer service representatives, Operations specialist at 888-456-7286 or Vice President, Clinical, Quality & Regulatory Affairs at 408-617-0352 x302, within the next 30 days. Note: FlowCardia Sales, Clinical and Customer support will send notification via certified mail or traceable courier and track response. If you have any questions or need any additional information email (dmichaels@flowcardia.com) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.

Device

Device Recall Crosser 14S Catheter
  • Model / Serial
    labeled shelf life code 2011-12, lot number 5053
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.
  • Product Description
    Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA || Intended use: Catheter for use in surgery.
  • Manufacturer
    Flowcardia Inc.

Manufacturer

Flowcardia Inc.
  • Manufacturer Address
    Flowcardia Inc., 745 N Pastoria Ave, Sunnyvale CA 94085-2918
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA