Events

Recall of CRN Crono

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intra Pump Infusion Systems.

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
    66541
  • Event Risk Class
    Class 2
  • Event Number
    Z-0099-2015
  • Event Initiated Date
    2013-10-18
  • Event Date Posted
    2014-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122569
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Product has the potential to have a clear debris on the tip of the needle.
  • Action
    Cane S.p.A. Medical Technology sent an Urgent: Correction and Removal Action Required letter dated October 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: a. Stop using the 19G x 11/2" 1.10 x 40mm steelneedle included in the CRONO Syringe blister pack. B. Safely discard the 19G x 11/2" 1.10 x 40mm steel needle into a Sharps container. c. Use a TRANSFER DEVICE (e.g.,Needleless adapter with female-to-female luer connector) or alternative device to transfer medications into the CRONO syringe. d.For intravenous infusions,we are recommending that a filter also be used during infusions. e. Complete the required 'Acknowledgment and Receipt Form'and fax back to our Distributor;Intra Pump Infusion Systems at 630-845-2768. Contact Information for our US Distributor: INTRA PUMP INFUSION SYSTEMS " Monday through Friday 8:00am to 5:00pm CST,TollFree:1-866- 211-7867 " Direct:630-845-7867 " Fax:630-845-2768 www.lntrapump.com

Device

CRN Crono
  • Model / Serial
    Product Code CRN20, lot numbers 14N02, 15E01, 15A02
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
  • Product Description
    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
  • Manufacturer
    Intra Pump Infusion Systems

Manufacturer

Intra Pump Infusion Systems
  • Manufacturer Address
    Intra Pump Infusion Systems, 920 Minters Chapel Rd Ste 200, Grapevine TX 76051-1302
  • Source
    USFDA