Events

Recall of Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Navilyst 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
    69085
  • Event Risk Class
    Class 2
  • Event Number
    Z-0027-2015
  • Event Initiated Date
    2014-08-25
  • Event Date Posted
    2014-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129622
  • 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
    Nmi was notified by the manufacturer of the 10 ml bd posiflush sf saline flush syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. based on the notification, nmi is recalling specific picc kits that contain the affected 10 ml bd posiflush sf saline flush syringes.
  • Action
    BD Medical sent an Urgent Voluntary Medical Device Recall letter dated July 22, 2014, to all affected customers via Federal Express on August 25, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and quarantine all affected product. Immediately discontinue shipment of the affected product. Complete the Recall Response Card form and fax it back to BD at 1-201-847-6990. If the affected product was further distributed cusotmers should identify their cusotmers and notify them immediately of the product recall. Customers with questions were instructed to contact BD Customer Service at 1-888-237-2762, option 3. For questions regarding this recall call 518-742-4571.

Device

Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit
  • Model / Serial
    Batch/Lot No. 4752351 (exp. 31-Jan-16)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- || Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
    Navilyst Medical, Inc
  • Source
    USFDA