Events

Recall of DualCap Solo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Catheter Connections, 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
    69066
  • Event Risk Class
    Class 2
  • Event Number
    Z-2595-2014
  • Event Initiated Date
    2014-08-05
  • Event Date Posted
    2014-09-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129487
  • 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
    Pad, alcohol, device disinfectant - Product Code LKB
  • Reason
    Catheter connections is recalling dualcap iv pole strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
  • Action
    The firm, Catheter Connections, sent an "Urgent: Medical Device Field Action" letter dated August 5, 2014 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to identify any customers who received this product having lot no. 1406509; make all potential users in your facility are made aware of this notification and the recommended actions; forward the attached URGENT MEDICAL DEVICE CORRECTION LETTER to customers immediately via fax or email; search your inventory and instruct all users to check each cap coming from the specific affected lot; quarantine and discard any defective product; and complete and return the attached URGENT MEDICAL DEVICE FIELD ACTION REPLY FORM via fax to 1-888-862-2693 or email to: info@cathconn.com. Catheter Connections does not require the return of devices having the affected lot number. If you have questions, please contact Catheter Connections at 1-801-906-0820 (M-F, 8:00 am - 5:00 pm MST) and ask for Quality Department.

Device

DualCap Solo
  • Model / Serial
    Lot 1406509
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CT, GA, MD, and PA. .
  • Product Description
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. || When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
  • Manufacturer
    Catheter Connections, Inc.

Manufacturer

Catheter Connections, Inc.
  • Manufacturer Address
    Catheter Connections, Inc., 615 Arapeen Dr Ste 302A, Salt Lake City UT 84108
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA